This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Triptorelin With Either Exemestane or Tamoxifen in Treating Premenopausal Women With Hormone-Responsive Breast Cancer (TEXT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00066703
Recruitment Status : Active, not recruiting
First Posted : August 7, 2003
Results First Posted : April 5, 2016
Last Update Posted : January 2, 2024
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Breast International Group
Information provided by (Responsible Party):
ETOP IBCSG Partners Foundation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer.

PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.


Condition or disease Intervention/treatment Phase
Breast Cancer Drug: exemestane Drug: tamoxifen Drug: triptorelin Phase 3

Detailed Description:

OBJECTIVES:

  • Compare the disease-free survival, breast cancer-free interval, distant recurrence-free interval and overall survival of premenopausal women with endocrine-responsive breast cancer when treated with triptorelin and exemestane vs triptorelin and tamoxifen.
  • Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens.

OUTLINE: This is a randomized, international, multicenter study. Patients are stratified according to planned use of concurrent adjuvant chemotherapy (yes vs no), and number of positive lymph nodes (0 vs 1 or more). Treatment duration is 5 years. Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase III Trial Evaluating The Role Of Exemestane Plus GnRH Analogue As Adjuvant Therapy For Premenopausal Women With Endocrine Responsive Breast Cancer
Study Start Date : November 3, 2003
Actual Primary Completion Date : March 11, 2011
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: T+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
 Drug: tamoxifen
Other Name: Nolvadex

Drug: triptorelin
Other Names:
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot
Experimental: E+OFS
Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
 Drug: exemestane
Other Name: Aromasin

Drug: triptorelin
Other Names:
  • GnRH analogue
  • Trelstar Depot
  • Decapeptyl Depot


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Disease-free Survival [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ]
    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.


Secondary Outcome Measures :
  1. Breast Cancer-free Interval [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ]
    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 the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up.

  2. Distant Recurrence-free Interval [ Time Frame: 5-year estimates reported at a median follow-up of 72 months ]
    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 breast cancer recurrence at a distant site; or censored at date of last follow-up

  3. Overall Survival [ Time Frame: 8-year estimates, reported at a median follow-up of 9 years ]
    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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

  • Completely resected disease

    • No clinically detectable residual loco-regional axillary disease

    • Prior surgery for primary breast cancer of 1 of the following types:

      • Total mastectomy with or without adjuvant radiotherapy
      • Breast-conserving procedure (e.g., lumpectomy, quadrantectomy, or partial mastectomy with margins negative* for invasive disease and ductal carcinoma in situ) with planned radiotherapy NOTE: *If all other margins are clear a positive posterior (deep) margin is permitted, provided the excision was performed down to the pectoral fascia and all tumor has been removed OR a positive anterior (superficial; abutting skin) margin is allowed provided all tumor was removed

  • Tumor confined to the breast and axillary nodes

    • Tumor detected in internal mammary chain nodes by sentinel node procedure and is not enlarged is allowed

  • Axillary lymph node dissection or a negative axillary sentinel node biopsy required

    • Patients with negative or microscopically positive axillary sentinel nodes are eligible
    • Positive sentinel nodes must have either axillary dissection or radiation of axillary nodes
  • No distant metastases

  • No locally advanced inoperable breast cancer, including any of the following:

    • Inflammatory breast cancer
    • Supraclavicular node involvement
    • Enlarged internal mammary nodes (unless pathologically negative)
  • Bilateral synchronous invasive breast cancer allowed if disease meets all other eligibility criteria
  • No prior ipsilateral or contralateral invasive breast cancer

  • Hormone receptor status:

    • Estrogen and/or progesterone receptor positive

      • At least 10% of the tumor cells positive by immunohistochemistry
      • If > 1 breast tumor, each tumor must be hormone receptor positive

PATIENT CHARACTERISTICS:

Age

  • Premenopausal

Sex

  • Female

Menopausal status

  • Premenopausal

    • Estradiol in the premenopausal range after prior surgery OR meets the following criteria:

      • Menstruating regularly for the past 6 months
      • Has not used any form of hormonal treatment (including hormonal contraception) within the past 6 months

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • No systemic hepatic disease that would preclude prolonged follow-up

Renal

  • No systemic renal disease that would preclude prolonged follow-up

Cardiovascular

  • No systemic cardiovascular disease that would preclude prolonged follow-up
  • No prior thrombosis (e.g., deep vein thrombosis) and/or embolism unless patient is medically suitable

Pulmonary

  • No systemic pulmonary disease that would preclude prolonged follow-up

Other

  • Not pregnant or nursing
  • Fertile patients must use effective nonhormonal contraception
  • No history of noncompliance to medical regimens
  • No other nonmalignant systemic disease that would preclude prolonged follow-up

  • No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:

    • Stage I papillary thyroid cancer
    • Stage IA carcinoma of the cervix
    • Stage IA or B endometrioid endometrial cancer
    • Borderline or stage I ovarian cancer
  • No psychiatric, addictive, or other disorder that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Prior or concurrent neoadjuvant or adjuvant trastuzumab allowed

Chemotherapy

  • No prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

  • No prior tamoxifen, other selective estrogen-receptor modulators (SERMs) (e.g., raloxifene), or hormone replacement therapy for more than 1 year before breast cancer diagnosis
  • No prior neoadjuvant or adjuvant endocrine therapy since diagnosis of breast cancer
  • No concurrent oral or transdermal hormonal therapy
  • No other concurrent estrogen, progesterone, or androgens
  • No other concurrent aromatase inhibitors
  • No concurrent oral or other hormonal contraceptives (i.e., implants or depot injections)

Radiotherapy

  • See Disease Characteristics
  • No prior ovarian radiotherapy

Surgery

  • See Disease Characteristics
  • No prior bilateral oophorectomy

Other

  • No concurrent bisphosphonates, except in the following cases:

    • Bone density is at least 1.5 standard deviations below the young adult normal mean
    • Participation in a randomized clinical study testing bisphosphonates in the adjuvant breast cancer setting
  • No other concurrent investigational agents
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066703


Locations
Show Show 228 study locations
Sponsors and Collaborators
ETOP IBCSG Partners Foundation
National Cancer Institute (NCI)
Breast International Group
Investigators
Layout table for investigator information
Study Chair: Olivia Pagani, MD Oncology Institute of Southern Switzerland
Study Chair: Barbara Walley, MD, FRCPC Tom Baker Cancer Centre
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Other Publications:
Francis P, Fleming G, Nasi ML, et al.: Tailored treatment investigations for premenopausal women with endocrine responsive (ER+ and/or PGR+) breast cancer: the SOFT, TEXT, and PERCHE trials. [Abstract] The Breast 12 (Suppl 1): A-P104, S44, 2003.

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

Layout table for additonal information
Responsible Party: ETOP IBCSG Partners Foundation
ClinicalTrials.gov Identifier: NCT00066703    
Other Study ID Numbers: IBCSG 25-02 / BIG 3-02
IBCSG 25-02
BIG 3-02 ( Other Identifier: Breast International Group )
NABCI IBCSG 25-02
EU-20347
2004-000168-28 ( EudraCT Number )
CDR0000316458 ( Registry Identifier: CT.gov )
First Posted: August 7, 2003    Key Record Dates
Results First Posted: April 5, 2016
Last Update Posted: January 2, 2024
Last Verified: December 2023
Keywords provided by ETOP IBCSG Partners Foundation:
stage II breast cancer
stage IIIA breast cancer
estrogen receptor-positive breast cancer
 progesterone receptor-positive breast cancer
stage IA breast cancer
stage IB breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Triptorelin Pamoate
Exemestane
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
 Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Hormonal