Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (SOFT)

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ClinicalTrials.gov Identifier: NCT00066690

Recruitment Status : Active, not recruiting

First Posted : August 7, 2003

Results First Posted : September 22, 2016

Last Update Posted : January 2, 2024

View this study on the modernized ClinicalTrials.gov

Sponsor:

Collaborators:

Breast International Group

Cancer and Leukemia Group B

National Cancer Institute (NCI)

NSABP Foundation Inc

NCIC Clinical Trials Group

North Central Cancer Treatment Group

SWOG Cancer Research Network

Information provided by (Responsible Party):

ETOP IBCSG Partners Foundation

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Conditions	Estrogen Receptor Positive Breast Cancer Progesterone Receptor Positive Tumor Recurrent Breast Carcinoma Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer
Interventions	Drug: Exemestane Other: Laboratory Biomarker Analysis Procedure: Oophorectomy Other: Quality-of-Life Assessment Radiation: Radiation Therapy Drug: Tamoxifen Drug: Triptorelin
Enrollment	3066

Participant Flow

Recruitment Details	3066 patients were randomized between 17Dec03 and 27Jan11 at 426 centers in 25 countries.
Pre-assignment Details


Arm/Group Title	Tamoxifen	T+OFS	E+OFS
Arm/Group Description	Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...
Arm/Group Description	Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Period Title: Overall Study
Started	1021	1024	1021
Completed	423	502	457
Not Completed	598	522	564
Reason Not Completed
Adverse Event	145	58	126
Death	3	0	2
Lack of Efficacy	114	110	76
Lost to Follow-up	40	21	29
Withdrawal by Subject	50	55	49
Treatment Ongoing	246	278	282

Baseline Characteristics

Arm/Group Title		Tamoxifen	T+OFS	E+OFS	Total
Arm/Group Description		Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...	Total of all reporting groups
Arm/Group Description		Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Total of all reporting groups
Overall Number of Baseline Participants		1018	1015	1014	3047
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Intention-to-treat population, excludes 19 patients who immediately withdrew consent.
Age, Continuous Median (Inter-Quartile Range) Unit of measure: Years
	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
		43 (38 to 46)	43 (38 to 47)	43 (38 to 47)	43 (38 to 47)
Sex/Gender, Customized ^[1] Measure Type: Number Unit of measure: Percent of participants	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
Female		100	100	100	300
Male		0	0	0	0
		[1] Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
American Indian/Alaskan native		1 0.1%	5 0.5%	3 0.3%	9 0.3%
Asian		36 3.5%	34 3.3%	33 3.3%	103 3.4%
Black/African American		32 3.1%	27 2.7%	34 3.4%	93 3.1%
Hawaiian/Pacific Islander		5 0.5%	4 0.4%	3 0.3%	12 0.4%
White/Caucasian		877 86.1%	873 86.0%	866 85.4%	2616 85.9%
Other		4 0.4%	2 0.2%	3 0.3%	9 0.3%
Unknown		19 1.9%	22 2.2%	22 2.2%	63 2.1%
Hispanic/Latino/South American native		44 4.3%	48 4.7%	50 4.9%	142 4.7%
Lymph-node status ^[1] Measure Type: Number Unit of measure: Percent of participants	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
Negative		65.03	65.22	66.17	196.42
Positive		34.97	34.78	33.83	103.58
		[1] Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Tumor size ^[1] Measure Type: Number Unit of measure: Percent of participants	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
Unknown		2.65	2.46	2.07	7.18
<=2 cm		66.40	64.63	66.86	197.89
>2cm		30.94	32.91	31.07	94.92
		[1] Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
Tumor grade ^[1] Measure Type: Number Unit of measure: Percent of participants	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
Unknown		2.36	2.36	2.17	6.89
1		27.01	26.11	24.36	77.48
2		48.33	50.64	53.65	152.62
3		22.30	20.89	19.82	63.01
		[1] Measure Description: Tumor grade is the histologic grade according to the BRE method. The method involves assessment of tumor morphology, including tubule formation, nuclear pleomorphism and frequency of mitoses. Grades are recorded according to criteria as 1,2 or 3. Grade 3 is associated with poor prognosis. Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.
HER2-status ^[1] Measure Type: Number Unit of measure: Percent of participants	Number Analyzed	1018 participants	1015 participants	1014 participants	3047 participants
Unknown		4.32	2.86	2.66	9.84
Negative		84.18	85.42	84.52	254.12
Positive		11.49	11.72	12.82	36.03
		[1] Measure Description: Units in this baseline measure reflect the percentage of total participants, rather than number of participants. The total provided does not equal the total number of participants and should not be interpreted as an accurate total of participants.

Outcome Measures

1.Primary Outcome


Title	Disease-free Survival
Description	Estimated percentage of patients alive and disease-free at 5 years fro...
Description	Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up.
Time Frame	5-year estimates, reported at a median follow-up of 67 months.

Outcome Measure Data

Analysis Population Description

Intention-to-treat


Arm/Group Title	Tamoxifen	T+OFS	E+OFS
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed	1018	1015	1014
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	84.7 (82.2 to 86.9)	86.6 (84.2 to 88.7)	89 (86.8 to 90.9)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, T+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.1
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95% 0.66 to 1.04
	Estimation Comments	Tamoxifen was the reference group in the estimation of the hazard ratio.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, E+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 95% 0.53 to 0.86
	Estimation Comments	Tamoxifen was the reference group in the estimation of the hazard ratio.

2.Secondary Outcome


Title	Breast Cancer-free Interval
Description	Estimated percentage of patients alive and disease-free at 5 years fro...
Description	Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast cancer-free interval is defined as the time from randomization to invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time Frame	5-year estimates, reported at a median follow-up of 67 months.

Outcome Measure Data

Analysis Population Description

Intention-to-treat


Arm/Group Title	Tamoxifen	T+OFS	E+OFS
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed	1018	1015	1014
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	86.4 (84.0 to 88.5)	88.4 (86.1 to 90.3)	90.9 (88.9 to 92.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, T+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.09
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 95% 0.3 to 1.03
	Estimation Comments	Tamoxifen was the reference group in the estimation of the hazard ratio.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, E+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.64
	Confidence Interval	(2-Sided) 95% 0.49 to 0.83
	Estimation Comments	Tamoxifen was the reference group in the estimation of the hazard ratio.

3.Secondary Outcome


Title	Distant Recurrence-free Interval
Description	Estimated percentage of patients alive and disease-free at 5 years fro...
Description	Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free Interval is defined as the time from randomization to invasive breast cancer recurrence at distant site, or invasive contralateral breast cancer; or censored at date of last follow up.
Time Frame	5-year estimates, reported at a median follow-up of 67 months.

Outcome Measure Data

Analysis Population Description

Intention-to-treat


Arm/Group Title	Tamoxifen	T+OFS	E+OFS
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
Overall Number of Participants Analyzed	1018	1015	1014
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	90.7 (88.6 to 92.4)	91.3 (89.2 to 92.9)	93.0 (91.2 to 94.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, T+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.40
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.88
	Confidence Interval	(2-Sided) 95% 0.66 to 1.18
	Estimation Comments	T was the reference group in the estimation of the hazard ratio.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, E+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.52 to 0.96
	Estimation Comments	T was the reference group in the estimation of hazard ratio.

4.Secondary Outcome


Title	Overall Survival
Description	Estimated percentage of patients alive at 8 years from randomization, ...
Description	Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.
Time Frame	8-year estimates, reported at a median follow-up of 8 years

Outcome Measure Data

Analysis Population Description

Intention-to-treat


Arm/Group Title	Tamoxifen	T+OFS	E+OFS
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...
Arm/Group Description:	Tamoxifen 20mg orally daily for 5 years Laboratory Biomarker Analysis: Correlative studies Quality-of-Life Assessment: Ancillary studies Tamoxifen: Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Tamoxifen: Tamoxifen 20mg orally daily for 5 years Triptorelin: 3.75 mg by im injection q28 days for 5 years	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation) Exemestane: Exemestane 25mg orally daily for 5 years plus ovarian function suppression Laboratory Biomarker Analysis: Correlative studies Oophorectomy: Undergo bilateral surgical oophorectomy Quality-of-Life Assessment: Ancillary studies Radiation Therapy: Undergo ovarian irradiation Triptorelin: 3.75 mg by im injection q28 days for 5 years
Overall Number of Participants Analyzed	1018	1015	1014
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: percentage of participants
	91.5 (89.4 to 93.2)	93.3 (91.4 to 94.8)	92.1 (90.0 to 93.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, T+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[not specified]

Statistical Test of Hypothesis	P-Value	0.01
	Comments	[Not Specified]
	Method	Log Rank
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.67
	Confidence Interval	(2-Sided) 95% 0.48 to 0.92
	Estimation Comments	T was the reference group in the estimation of the hazard ratio

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tamoxifen, E+OFS
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[not specified]

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 95% 0.62 to 1.15
	Estimation Comments	T was the reference group in the estimation of hazard ratio

Adverse Events

Time Frame	Assessed every 3 months for the first year, then every 6 month until year 6. Reported at a median follow-up of 67 months.
Adverse Event Reporting Description	Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution. The safety population EXCLUDES patients who never started protocol-assigned therapy.

Arm/Group Title	Tamoxifen	T+OFS	E+OFS
Arm/Group Description	Tamoxifen 20mg orally daily for 5 y...	Tamoxifen 20mg orally daily for 5 y...	Exemestane 25mg orally daily for 5 ...
Arm/Group Description	Tamoxifen 20mg orally daily for 5 years	Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)	Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
All-Cause Mortality
	Tamoxifen	T+OFS	E+OFS
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	87/1007 (8.64%)	68/1007 (6.75%)	80/1001 (7.99%)
Serious Adverse Events Serious Adverse Events
	Tamoxifen	T+OFS	E+OFS
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	315/1007 (31.28%)	375/1007 (37.24%)	375/1001 (37.46%)
Blood and lymphatic system disorders
Hemoglobin ^† 1	2/1007 (0.20%)	2/1007 (0.20%)	2/1001 (0.20%)
Cardiac disorders
Cardiac Arrhythmia-Other (Specify) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Cardiac-ischemia/infarction ^† 1	4/1007 (0.40%)	1/1007 (0.10%)	3/1001 (0.30%)
Conduction abnormality/Atrioventricular heart block - AV block-third degree (complete AV block) ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Conduction abnormality/Atrioventricular heart block - Sick sinus syndrome ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Left ventricular diastolic dysfunction ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Left ventricular systolic dysfunction ^† 1	0/1007 (0.00%)	2/1007 (0.20%)	3/1001 (0.30%)
Pain - Cardiac/heart ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Restrictive cardiomyopathy ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Right ventricular dysfunction (cor pulmonale) ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Supraventricular and nodal arrhythmia - Atrial fibrillation ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Supraventricular and nodal arrhythmia - Sinus arrhythmia ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Supraventricular and nodal arrhythmia - Supraventricular tachycardia ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Valvular heart disease ^† 1	2/1007 (0.20%)	0/1007 (0.00%)	0/1001 (0.00%)
Ear and labyrinth disorders
Auditory/Ear-Other (Specify) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Hearing: patients without baseline audiogram and not enrolled in a monitoring program ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	1/1001 (0.10%)
Endocrine disorders
Thyroid function, high (hyperthyroidism, thyrotoxicosis) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Thyroid function, low (hypothyroidism) ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Adrenal insufficiency ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Endocrine-Other (Specify) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Eye disorders
Cataract ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	1/1001 (0.10%)
Ocular/Visual-Other (Specify) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Optic disc edema ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Retinal detachment ^† 1	3/1007 (0.30%)	1/1007 (0.10%)	1/1001 (0.10%)
Vision-flashing lights/floaters ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Gastrointestinal disorders
Distention/bloating, abdominal ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Necrosis, GI - Ileum ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Obstruction, GI - Small bowel NOS ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Stricture/stenosis (including anastomotic), GI - Small bowel NOS ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Ulcer, GI - Anus ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Colitis ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	1/1001 (0.10%)
Constipation ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Diarrhea ^† 1	1/1007 (0.10%)	2/1007 (0.20%)	1/1001 (0.10%)
Dysphagia (difficulty swallowing) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Gastrointestinal-Other (Specify) ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	2/1001 (0.20%)
Heartburn/dyspepsia ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Hemorrhoids ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Mucositis/stomatitis (functional/symptomatic) - Oral cavity ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Nausea ^† 1	0/1007 (0.00%)	4/1007 (0.40%)	2/1001 (0.20%)
Pain - Abdomen NOS ^† 1	3/1007 (0.30%)	3/1007 (0.30%)	4/1001 (0.40%)
Pain - Rectum ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Pancreatitis ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Vomiting ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
General disorders
Fatigue (asthenia, lethargy, malaise) ^† 1	32/1007 (3.18%)	36/1007 (3.57%)	33/1001 (3.30%)
Death not associated with CTCAE term - Death NOS ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Death not associated with CTCAE term - Sudden death ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Edema: limb ^† 1	2/1007 (0.20%)	0/1007 (0.00%)	0/1001 (0.00%)
Flu-like syndrome ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Injection site reaction/extravasation changes ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Pain - Chest/thorax NOS ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	2/1001 (0.20%)
Pain-Other (Specify) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	1/1001 (0.10%)
Hepatobiliary disorders
Cholecystitis ^† 1	2/1007 (0.20%)	2/1007 (0.20%)	2/1001 (0.20%)
Hepatobiliary/Pancreas-Other (Specify) ^† 1	3/1007 (0.30%)	2/1007 (0.20%)	4/1001 (0.40%)
Liver dysfunction/failure (clinical) ^† 1	1/1007 (0.10%)	5/1007 (0.50%)	1/1001 (0.10%)
Pain - Gallbladder ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) ^† 1	1/1007 (0.10%)	2/1007 (0.20%)	6/1001 (0.60%)
Allergy/Immunology-Other (Specify) ^† 1	0/1007 (0.00%)	2/1007 (0.20%)	0/1001 (0.00%)
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Foreign body (e.g., graft, implant) ^† 1	1/1007 (0.10%)	2/1007 (0.20%)	1/1001 (0.10%)
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Skin (cellulitis) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Infection (documented clinically or microbiologically) w/Grade 3 or 4 neutrophils -Urinary tract NOS ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Infection (documented clinically/microbiologically) w/Grade 3/4 neutrophils -Gallbladder ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Abdomen NOS ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Appendix ^† 1	1/1007 (0.10%)	2/1007 (0.20%)	1/1001 (0.10%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Bladder (urinary) ^† 1	1/1007 (0.10%)	1/1007 (0.10%)	1/1001 (0.10%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Kidney ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia) ^† 1	2/1007 (0.20%)	3/1007 (0.30%)	0/1001 (0.00%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Pelvis NOS ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis) ^† 1	4/1007 (0.40%)	10/1007 (0.99%)	12/1001 (1.20%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Soft tissue NOS ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Urinary tract NOS ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	2/1001 (0.20%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Vagina ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Infection with normal ANC or Grade 1 or 2 neutrophils - Wound ^† 1	3/1007 (0.30%)	3/1007 (0.30%)	1/1001 (0.10%)
Infection with unknown ANC - Heart (endocarditis) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Infection with unknown ANC - Rectum ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Infection with unknown ANC - Skin (cellulitis) ^† 1	3/1007 (0.30%)	2/1007 (0.20%)	1/1001 (0.10%)
Infection with unknown ANC - Wound ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Infection-Other (Specify) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	2/1001 (0.20%)
Injury, poisoning and procedural complications
Hemorrhage/bleeding associated with surgery, intra-operative or post-operative ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Wound complication, non-infectious ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Fracture ^† 1	8/1007 (0.79%)	8/1007 (0.79%)	12/1001 (1.20%)
Intra-operative injury - Vein NOS ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Rash: dermatitis associated with radiation - Radiation ^† 1	2/1007 (0.20%)	0/1007 (0.00%)	1/1001 (0.10%)
Thrombosis/embolism (vascular access-related) ^† 1	17/1007 (1.69%)	17/1007 (1.69%)	7/1001 (0.70%)
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase) ^† 1	1/1007 (0.10%)	3/1007 (0.30%)	2/1001 (0.20%)
AST, SGOT (serum glutamic oxaloacetic transaminase) ^† 1	1/1007 (0.10%)	1/1007 (0.10%)	0/1001 (0.00%)
Creatinine ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
GGT (gamma-glutamyl transpeptidase) ^† 1	2/1007 (0.20%)	3/1007 (0.30%)	5/1001 (0.50%)
Leukocytes (total WBC) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Weight loss ^† 1	0/1007 (0.00%)	2/1007 (0.20%)	2/1001 (0.20%)
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia) ^† 1	1/1007 (0.10%)	9/1007 (0.89%)	5/1001 (0.50%)
Potassium, serum-low (hypokalemia) ^† 1	2/1007 (0.20%)	2/1007 (0.20%)	0/1001 (0.00%)
Iron overload ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Pancreatic endocrine: glucose intolerance ^† 1	3/1007 (0.30%)	14/1007 (1.39%)	3/1001 (0.30%)
Musculoskeletal and connective tissue disorders
Arthritis (non-septic) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Lumbar spine-range of motion ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Musculoskeletal/Soft Tissue-Other (Specify) ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	3/1001 (0.30%)
Myositis (inflammation/damage of muscle) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Osteoporosis ^† 1	1/1007 (0.10%)	3/1007 (0.30%)	2/1001 (0.20%)
Pain - Back ^† 1	1/1007 (0.10%)	1/1007 (0.10%)	1/1001 (0.10%)
Pain - Chest wall ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	1/1001 (0.10%)
Pain - Extremity-limb ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Pain - Joint ^† 1	64/1007 (6.36%)	55/1007 (5.46%)	119/1001 (11.89%)
Pain - Muscle ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Nervous system disorders
Hemorrhage, CNS ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
CNS cerebrovascular ischemia ^† 1	4/1007 (0.40%)	1/1007 (0.10%)	3/1001 (0.30%)
Cognitive disturbance ^† 1	1/1007 (0.10%)	1/1007 (0.10%)	1/1001 (0.10%)
Dizziness ^† 1	3/1007 (0.30%)	0/1007 (0.00%)	5/1001 (0.50%)
Memory impairment ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Myelitis ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Neurology-Other (Specify) ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	2/1001 (0.20%)
Neuropathy: cranial - CN V Motor-jaw muscles; Sensory-facial ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Neuropathy: cranial - CN VIII Hearing and balance ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	1/1001 (0.10%)
Neuropathy: sensory ^† 1	1/1007 (0.10%)	5/1007 (0.50%)	4/1001 (0.40%)
Pain - Head/headache ^† 1	6/1007 (0.60%)	10/1007 (0.99%)	10/1001 (1.00%)
Pain - Neuralgia/peripheral nerve ^† 1	0/1007 (0.00%)	2/1007 (0.20%)	6/1001 (0.60%)
Syncope (fainting) ^† 1	1/1007 (0.10%)	2/1007 (0.20%)	4/1001 (0.40%)
Vasovagal episode ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Psychiatric disorders
Insomnia ^† 1	29/1007 (2.88%)	46/1007 (4.57%)	45/1001 (4.50%)
Mood alteration - anxiety ^† 1	2/1007 (0.20%)	2/1007 (0.20%)	1/1001 (0.10%)
Mood alteration - depression ^† 1	38/1007 (3.77%)	44/1007 (4.37%)	37/1001 (3.70%)
Psychosis (hallucinations/delusions) ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Renal and urinary disorders
Incontinence, urinary ^† 1	6/1007 (0.60%)	5/1007 (0.50%)	4/1001 (0.40%)
Obstruction, GU - Ureter ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	4/1001 (0.40%)
Stricture/stenosis (including anastomotic), GU - Ureter ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Renal failure ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Renal/Genitourinary-Other (Specify) ^† 1	49/1007 (4.87%)	19/1007 (1.89%)	11/1001 (1.10%)
Reproductive system and breast disorders
Hemorrhage, GU - Ovary ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Hemorrhage, GU - Uterus ^† 1	5/1007 (0.50%)	1/1007 (0.10%)	3/1001 (0.30%)
Hemorrhage, GU - Vagina ^† 1	5/1007 (0.50%)	1/1007 (0.10%)	1/1001 (0.10%)
Stricture/stenosis (including anastomotic), GU - Uterus ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Irregular menses (change from baseline) ^† 1	4/1007 (0.40%)	2/1007 (0.20%)	0/1001 (0.00%)
Pain - Breast ^† 1	2/1007 (0.20%)	0/1007 (0.00%)	1/1001 (0.10%)
Pain - Ovulatory ^† 1	1/1007 (0.10%)	1/1007 (0.10%)	0/1001 (0.00%)
Pain - Pelvis ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Pain - Vagina ^† 1	14/1007 (1.39%)	22/1007 (2.18%)	19/1001 (1.90%)
Sexual/Reproductive Function-Other (Specify) ^† 1	0/1007 (0.00%)	2/1007 (0.20%)	2/1001 (0.20%)
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g., hoarseness, loss or alteration in voice, laryngitis) ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Apnea ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	2/1001 (0.20%)
Dyspnea (shortness of breath) ^† 1	2/1007 (0.20%)	2/1007 (0.20%)	2/1001 (0.20%)
Hypoxia ^† 1	1/1007 (0.10%)	1/1007 (0.10%)	0/1001 (0.00%)
Obstruction/stenosis of airway - Bronchus ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Pain - Pleura ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Pleural effusion (non-malignant) ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Pneumonitis/pulmonary infiltrates ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) ^† 1	0/1007 (0.00%)	0/1007 (0.00%)	1/1001 (0.10%)
Dermatology/Skin-Other (Specify) ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	0/1001 (0.00%)
Pain - Skin ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Pruritus/itching ^† 1	0/1007 (0.00%)	3/1007 (0.30%)	0/1001 (0.00%)
Soft tissue necrosis - Thorax ^† 1	0/1007 (0.00%)	1/1007 (0.10%)	0/1001 (0.00%)
Vascular disorders
Hematoma ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
Hot flashes/flushes ^† 1	76/1007 (7.55%)	133/1007 (13.21%)	107/1001 (10.69%)
Hypertension ^† 1	54/1007 (5.36%)	75/1007 (7.45%)	68/1001 (6.79%)
Thrombosis/thrombus/embolism ^† 1	0/1007 (0.00%)	2/1007 (0.20%)	0/1001 (0.00%)
Vascular-Other (Specify) ^† 1	1/1007 (0.10%)	0/1007 (0.00%)	0/1001 (0.00%)
1 Term from vocabulary, CTCAE (3.0) † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Tamoxifen	T+OFS	E+OFS
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	951/1007 (94.44%)	982/1007 (97.52%)	980/1001 (97.90%)
Cardiac disorders
Cardiac-ischemia/infarction ^† 1	1/1007 (0.10%)	2/1007 (0.20%)	5/1001 (0.50%)
Gastrointestinal disorders
Nausea ^† 1	239/1007 (23.73%)	215/1007 (21.35%)	228/1001 (22.78%)
General disorders
Fatigue (asthenia, lethargy, malaise) ^† 1	571/1007 (56.70%)	595/1007 (59.09%)	591/1001 (59.04%)
Injection site reaction/extravasation changes ^† 1	4/1007 (0.40%)	88/1007 (8.74%)	84/1001 (8.39%)
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever) ^† 1	31/1007 (3.08%)	42/1007 (4.17%)	46/1001 (4.60%)
Injury, poisoning and procedural complications
Fracture ^† 1	41/1007 (4.07%)	46/1007 (4.57%)	51/1001 (5.09%)
Thrombosis/embolism (vascular access-related) ^† 1	5/1007 (0.50%)	3/1007 (0.30%)	2/1001 (0.20%)
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia) ^† 1	15/1007 (1.49%)	37/1007 (3.67%)	17/1001 (1.70%)
Pancreatic endocrine: glucose intolerance ^† 1	15/1007 (1.49%)	21/1007 (2.09%)	28/1001 (2.80%)
Musculoskeletal and connective tissue disorders
Osteoporosis ^† 1	123/1007 (12.21%)	198/1007 (19.66%)	316/1001 (31.57%)
Pain - Joint ^† 1	631/1007 (62.66%)	700/1007 (69.51%)	778/1001 (77.72%)
Nervous system disorders
Hemorrhage, CNS ^† 1	14/1007 (1.39%)	9/1007 (0.89%)	8/1001 (0.80%)
CNS cerebrovascular ischemia ^† 1	2/1007 (0.20%)	1/1007 (0.10%)	0/1001 (0.00%)
Psychiatric disorders
Insomnia ^† 1	437/1007 (43.40%)	529/1007 (52.53%)	549/1001 (54.85%)
Libido ^† 1	427/1007 (42.40%)	477/1007 (47.37%)	492/1001 (49.15%)
Mood alteration - depression ^† 1	431/1007 (42.80%)	478/1007 (47.47%)	476/1001 (47.55%)
Renal and urinary disorders
Incontinence, urinary ^† 1	156/1007 (15.49%)	180/1007 (17.87%)	120/1001 (11.99%)
Reproductive system and breast disorders
Pain - Vagina ^† 1	224/1007 (22.24%)	240/1007 (23.83%)	290/1001 (28.97%)
Vaginal dryness ^† 1	421/1007 (41.81%)	500/1007 (49.65%)	541/1001 (54.05%)
Skin and subcutaneous tissue disorders
Sweating (diaphoresis) ^† 1	486/1007 (48.26%)	621/1007 (61.67%)	566/1001 (56.54%)
Vascular disorders
Hot flashes/flushes ^† 1	727/1007 (72.19%)	806/1007 (80.04%)	820/1001 (81.92%)
Hypertension ^† 1	119/1007 (11.82%)	158/1007 (15.69%)	165/1001 (16.48%)
1 Term from vocabulary, CTCAE (3.0) † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

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Name/Title:	Dr. Heidi Roschitzki-Voser, Head Trial Activities/Deputy Director
Organization:	ETOP IBCSG Partners Foundation
Phone:	+41 31 511 94 00
EMail:	heidi.roschitzki@etop.ibcsg.org

Publications of Results:

Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, Bonnefoi HR, Climent MA, Da Prada GA, Burstein HJ, Martino S, Davidson NE, Geyer CE Jr, Walley BA, Coleman R, Kerbrat P, Buchholz S, Ingle JN, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Colleoni M, Viale G, Coates AS, Goldhirsch A, Gelber RD; SOFT Investigators; International Breast Cancer Study Group. Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29;372(5):436-46. doi: 10.1056/NEJMoa1412379. Epub 2014 Dec 11.

Francis PA, Fleming GF, Lang I, Ciruelos EM, Bonnefoi HR, Bellet M, Bernardo A, Climent MA, Martino S, Bermejo B, Burstein HJ, Davidson NE, Geyer CE Jr, Walley BA, Ingle JN, Coleman RE, Muller B, Le Du F, Loibl S, Winer EP, Ruepp B, Loi S, Colleoni M, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT Investigators and the International Breast Cancer Study Group (a division of ETOP IBCSG Partners Foundation). Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 1;41(7):1370-1375. doi: 10.1200/JCO.22.01065. Epub 2022 Dec 9. Erratum In: J Clin Oncol. 2023 Sep 1;41(25):4187.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Pagani O, Francis PA, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Di Leo A, Coates AS, Goldhirsch A, Gelber RD, Regan MM; SOFT and TEXT Investigators and International Breast Cancer Study Group. Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT. J Clin Oncol. 2020 Apr 20;38(12):1293-1303. doi: 10.1200/JCO.18.01967. Epub 2019 Oct 16.

Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, Gomez HL, Tondini C, Ciruelos E, Burstein HJ, Bonnefoi HR, Bellet M, Martino S, Geyer CE Jr, Goetz MP, Stearns V, Pinotti G, Puglisi F, Spazzapan S, Climent MA, Pavesi L, Ruhstaller T, Davidson NE, Coleman R, Debled M, Buchholz S, Ingle JN, Winer EP, Maibach R, Rabaglio-Poretti M, Ruepp B, Di Leo A, Coates AS, Gelber RD, Goldhirsch A, Regan MM; SOFT and TEXT Investigators and the International Breast Cancer Study Group. Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12;379(2):122-137. doi: 10.1056/NEJMoa1803164. Epub 2018 Jun 4.

Regan MM, Walley BA, Francis PA, Fleming GF, Lang I, Gomez HL, Colleoni M, Tondini C, Pinotti G, Salim M, Spazzapan S, Parmar V, Ruhstaller T, Abdi EA, Gelber RD, Coates AS, Goldhirsch A, Pagani O. Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol. 2017 Sep 1;28(9):2225-2232. doi: 10.1093/annonc/mdx285.

Regan MM, Francis PA, Pagani O, Fleming GF, Walley BA, Viale G, Colleoni M, Lang I, Gomez HL, Tondini C, Pinotti G, Price KN, Coates AS, Goldhirsch A, Gelber RD. Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 Jul 1;34(19):2221-31. doi: 10.1200/JCO.2015.64.3171. Epub 2016 Apr 4.

Ribi K, Luo W, Bernhard J, Francis PA, Burstein HJ, Ciruelos E, Bellet M, Pavesi L, Lluch A, Visini M, Parmar V, Tondini C, Kerbrat P, Perello A, Neven P, Torres R, Lombardi D, Puglisi F, Karlsson P, Ruhstaller T, Colleoni M, Coates AS, Goldhirsch A, Price KN, Gelber RD, Regan MM, Fleming GF. Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol. 2016 May 10;34(14):1601-10. doi: 10.1200/JCO.2015.64.8675. Epub 2016 Mar 28.

Bernhard J, Luo W, Ribi K, Colleoni M, Burstein HJ, Tondini C, Pinotti G, Spazzapan S, Ruhstaller T, Puglisi F, Pavesi L, Parmar V, Regan MM, Pagani O, Fleming GF, Francis PA, Price KN, Coates AS, Gelber RD, Goldhirsch A, Walley BA. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol. 2015 Jul;16(7):848-58. doi: 10.1016/S1470-2045(15)00049-2. Epub 2015 Jun 16.

Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.

Regan MM, Pagani O, Fleming GF, Walley BA, Price KN, Rabaglio M, Maibach R, Ruepp B, Coates AS, Goldhirsch A, Colleoni M, Gelber RD, Francis PA; International Breast Cancer Study; GroupSOFT and TEXT Investigators. Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec;22(6):1094-100. doi: 10.1016/j.breast.2013.08.009. Epub 2013 Oct 2.

Layout table for additonal information

Responsible Party:	ETOP IBCSG Partners Foundation
ClinicalTrials.gov Identifier:	NCT00066690
Obsolete Identifiers:	NCT00917969, NCT02140190
Other Study ID Numbers:	IBCSG 24-02 / BIG 2-02 NCI-2009-01086 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) CDR0000316456 BIG 2-02 2004-000166-13 IBCSG-24-02 ( Other Identifier: CTEP ) U24CA075362 ( U.S. NIH Grant/Contract )
First Submitted:	August 6, 2003
First Posted:	August 7, 2003
Results First Submitted:	July 14, 2015
Results First Posted:	September 22, 2016
Last Update Posted:	January 2, 2024

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