Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

• ClinicalTrials.gov Identifier: NCT02445391
• Recruitment Status: Active, not recruiting
• First Posted: May 15, 2015
• Results First Posted: October 5, 2022
• Last Update Posted: July 10, 2023
• Sponsor: ECOG-ACRIN Cancer Research Group
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Estrogen Receptor Negative; HER2/Neu Negative; Invasive Breast Carcinoma; Progesterone Receptor Negative; Stage II Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage III Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Triple-Negative Breast Carcinoma
• Interventions: Drug: Capecitabine; Drug: Carboplatin; Drug: Cisplatin
• Enrollment: 415

Participant Flow

Recruitment Details

This study was activated on April 29, 2015, with the first accrual on October 20, 2015. Accrual was temporarily suspended on December 28, 2015. The study was reactivated on June 22, 2016 to continue enrollment of patients to arms B and C (capecitabine), and accrual to arm A was permanently closed. Patient accrual was closed on March 30, 2021 with final accrual of 560 patients to step 0 and 415 patients randomized to step 1. Only 415 patients enrolled at Step 1 are included in the analysis.

Pre-assignment Details

Before randomization patients were tested about their intrinsic subtype using PAM50 assay at step 0. Before amendment #3, only basal subtype was eligible and was randomized. After amendment #3, all patients were eligible regardless of intrinsic subtype, and intrinsic subtype was added as a stratification factor. After amendment #7 (activated in November 2020), intrinsic subtype was no longer a stratification factor, patients were randomized as long as tumor specimen was submitted for PAM50 test.

Arm/Group Title	Arm A (Observation) (Closed to Accrual 05/16/2016)	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Arm/Group Description	Patients undergo observation, and receive no active treatment.	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
Period Title: Overall Study
Started [1]	3 [2]	199 [3]	213
Concurrently Randomized to Arms B and C	0	197	213
Concurrently Randomized to Arms A and B	3	2	0
Started Protocol Therapy	0	187	204
Reported Treatment Data	0	185	199
Reported Adverse Event Data [4]	0	186	201
Reported Mortality Data	3	199	213
Basal-subtype Disease	3	150 [5]	160
Basal-subtype Disease Randomized After 6/22/2016 [6]	0	148	160
Non Basal-subtype Disease [7]	0	42	46
Intrinsic Subtype Unknown [8]	0	7	7
Reported Health-related Quality of Life Data at 6 Months Assessment	0	69	84
Reported Health-related Quality of Life Data at 15 Months Assessment	0	37	54
Completed	0	146	141
Not Completed	3	53	72
Reason Not Completed
No active protocol treatment	3	0	0
Adverse Event	0	21	12
Alternative therapy	0	0	1
Disease progression	0	7	22
Complicating disease	0	2	1
Withdrawal by Subject	0	4	9
Financial issue	0	0	2
Still on treatment	0	7	16
Not start protocol therapy	0	12	9
[1] All patients who were randomized to one of the three arms in the trial throughout the accrual period between April 2015 and March 2021.; [2] Patients on arm A were under observation, and there was no specified active protocol therapy.; [3] 2 patients were assigned to arm B before 6/22/2106 (activation date of amendment #3), 197 patients were assigned to arm B after 6/22/2016. Arm A was permanently closed to accrual by 6/22/2016 and arm C was open to accrual after 6/22/2016.; [4] This is the analysis population for adverse event outcomes; [5] 2 patients with basal-subtype disease were assigned to arm B before 6/22/2016; 148 patients with basal-subtype disease were assigned to arm B after 6/22/2016.; [6] This is the primary analysis population for IDFS (primary endpoint) and OS and RFS (secondary endpoints).; [7] Intrinsic subtype was added as a stratification factor in amendment #3 (activated on 6/22/2016), all eligible patients regardless of intrinsic subtype were randomized to arms B and C; [8] In amendment #7 (activated in Nov 2020), intrinsic subtype was removed as a stratification factor, all patients were randomized to arms B and C as long as they submitted tumor specimen for PAM50 test. Intrinsic subtype was not known at randomization. At the time of the final analysis, intrinsic subtype was still pending for these patients.

Baseline Characteristics

Arm/Group Title		Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)	Total
Arm/Group Description		Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO	Total of all reporting groups
Overall Number of Baseline Participants		148	160	308
Baseline Analysis Population Description		All patients who were concurrently randomized to arms B and C after 6/22/2016 and had basal-subtype disease, this was the primary analysis population for IDFS and other secondary efficacy endpoints (OS and RFS). Only patients included in the primary analysis are included in the analysis of baseline characteristics.
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	148 participants	160 participants	308 participants
		52; (27 to 72)	52; (26 to 76)	52; (26 to 76)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	148 participants	160 participants	308 participants
	Female	148 100.0%	160 100.0%	308 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	148 participants	160 participants	308 participants
	Hispanic or Latino	18 12.2%	15 9.4%	33 10.7%
	Not Hispanic or Latino	123 83.1%	136 85.0%	259 84.1%
	Unknown or Not Reported	7 4.7%	9 5.6%	16 5.2%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	148 participants	160 participants	308 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	3 2.0%	7 4.4%	10 3.2%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	28 18.9%	31 19.4%	59 19.2%
	White	104 70.3%	115 71.9%	219 71.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	13 8.8%	7 4.4%	20 6.5%

Outcome Measures

1. Primary Outcome

Title	3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients
Description	IDFS was defined to be time from randomization to the earliest of documented disease recurrence (local, regional and/or distant), invasive contralateral breast cancer, invasive any other second cancer, or death. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of IDFS events. 3-year IDFS rate was estimated using Kaplan-Meier method.
Time Frame	No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.

Outcome Measure Data

Analysis Population Description

The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

Arm/Group Title	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Arm/Group Description:	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
Overall Number of Participants Analyzed	148	160
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	42.0; (30.5 to 53.1)	49.4; (39.0 to 59.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open), Arm C (Capecitabine) (Open to Accrual 6/22/2016)
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	The null hypothesis for testing non-inferiority of platinum was defined as that the hazard ratio (HR) for platinum/capecitabine ≥ 1.154 (ie, HR of 1.154 was used as the non-inferiority margin). The alternative hypothesis was HR=0.754 for platinum/ capecitabine. The 4-year IDFS rate was expected to be 67% on capecitabine arm.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.06
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.81
	Estimation Comments	The 95% confidence interval provided above was the Jennison and Turnbull repeated confidence interval.

2. Secondary Outcome

Title	3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients
Description	RFS was defined as time from randomization to local/regional recurrence, distant recurrence or death, whichever occurred first. Cases with incomplete follow up or without adequate disease evaluations were censored at the date last documented to be free of RFS events. 3-year RFS rate was estimated using Kaplan-Meier method.
Time Frame	No mandatory timeline, assessed at any time as a standard of care procedure or at the investigator's discretion; data reported every 3 months within 2 years from randomization, every 6 months if 2-3 years.

Outcome Measure Data

Analysis Population Description

The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

Arm/Group Title	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Arm/Group Description:	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
Overall Number of Participants Analyzed	148	160
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	46.2; (34.7 to 57.0)	49.3; (38.9 to 58.9)

3. Secondary Outcome

Title	3-year Overall Survival (OS) Rate in Basal-Subtype Patients
Description	OS was defined as time from randomization to death from any cause. Patient alive were censored at date of known alive. The 3-year OS rate was estimated using Kaplan-Meier method.
Time Frame	Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years

Outcome Measure Data

Analysis Population Description

The primary analysis population was all basal-subtype TNBC patients who were concurrently randomized to arms B and C after 6/22/2016 (intent-to-treat population).

Arm/Group Title	Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Arm/Group Description:	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
Overall Number of Participants Analyzed	148	160
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	57.8; (45.2 to 68.4)	66.2; (56.3 to 74.3)

4. Secondary Outcome

Title	Proportion of Basal Subtype
Description	Proportion of basal subtype was calculated as number of patients who had basal subtype disease divided by all triple-negative breast cancers who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype results.
Time Frame	Assessed at registration to step 0 (baseline)

Outcome Measure Data

Analysis Population Description

Analysis population was all patients who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype results. Before 6/22/2016, only basal subtype was randomized to arms A and B. After 6/22/2016, all eligible patients were randomized to arms B and C regardless of their intrinsic subtype. Proportion of basal subtype was calculated in the 396 patients who were randomized to arms B and C after 6/22/2016 and had intrinsic subtype assay results at the final analysis time.

Arm/Group Title	All Patients Concurrently Randomized to Arms B and C
Arm/Group Description:	All patients who were randomized to arms B and C after 6/22/2016 (when arm C was open to accrual). Before 6/22/2016, only basal subtype was randomized to arms A and B. After 6/22/2016, all eligible patients were randomized regardless of their intrinsic subtype. Proportion of basal subtype was calculated in patients randomized after 6/22/2016.
Overall Number of Participants Analyzed	396
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	78; (73 to 82)

5. Secondary Outcome

Title	Health-related Quality of Life (HRQL) at 6-month Assessment
Description	HRQL was measured by the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI) Treatment Side Effects (TSE) subscale score, an aggregate score of 4 items (GP2, GP5, N6 and B5) from the FBSI-16 scale. The FBSI TSE subscale score was calculated based on the scoring manual, score ranges from 0 to 16, higher scores indicate better quality of life.
Time Frame	Assessed at 6 months after randomization

Outcome Measure Data

Analysis Population Description

All patients randomized to arms B and C and reported health-related quality of life data at 6-month assessment

Arm/Group Title	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Arm/Group Description:	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
Overall Number of Participants Analyzed	69	84
Mean (Standard Deviation); Unit of Measure: score on a scale
	14.7 (1.8)	14.6 (1.7)

6. Secondary Outcome

Title	Health-related Quality of Life (HRQL) at 15-month Assessment
Description	HRQL was measured by the Functional Assessment of Cancer Therapy Breast Symptom Index (FBSI) Treatment Side Effects (TSE) subscale score, an aggregate score of 4 items (GP2, GP5, N6 and B5) from the FBSI-16 scale. The FBSI TSE subscale score was calculated based on the scoring manual, score ranges from 0 to 16, higher scores indicate better quality of life.
Time Frame	Assessed at 15 months after randomization

Outcome Measure Data

Analysis Population Description

All patients randomized to arms B and C and reported health-related quality of life data at 15-month assessment

Arm/Group Title	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine) (Open to Accrual 6/22/2016)
Arm/Group Description:	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
Overall Number of Participants Analyzed	37	54
Mean (Standard Deviation); Unit of Measure: score on a scale
	14.5 (2.3)	14.9 (1.8)

Adverse Events

Time Frame	Assessed every 3 weeks (1 cycle=3 weeks) while on treatment and for 30 days after the end of treatment. During long-term follow-up period, adverse events were assessed every 3 months if <2 years from randomization, every 6 months if 2-5 years from randomization, and then annually until 10 years from randomization. The adverse event data reported in this section were collected up to 7 years from randomization.
Adverse Event Reporting Description	Only patients who received protocol therapy and reported adverse events data were included in the analysis of adverse events. All randomized patients were included in the analysis of all-cause mortality. The two patients who were randomized to arm B prior to 6/22/2016 were also included in the safety analysis. The three patients enrolled in arm A did not receive any treatment as they were on observation so no adverse events were collected.
Arm/Group Title	Arm A (Observation)	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine)
Arm/Group Description	Patients were on observation and did not receive any treatment.	Patients receive cisplatin IV or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Carboplatin: Given IV Cisplatin: Given IV	Patients receive capecitabine PO BID on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Capecitabine: Given PO
All-Cause Mortality
	Arm A (Observation)	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	2/3 (66.67%)	51/199 (25.63%)	45/213 (21.13%)
Serious Adverse Events
	Arm A (Observation)	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	50/186 (26.88%)	32/201 (15.92%)
Blood and lymphatic system disorders
Anemia † 1	/0	14/186 (7.53%)	0/201 (0.00%)
Febrile neutropenia † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Thrombotic thrombocytopenic purpura † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Blood and lymphatic system disorders - Other, specify † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Cardiac disorders
Cardiac disorders - Other, specify † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Ear and labyrinth disorders
Hearing impaired † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Gastrointestinal disorders
Colitis † 1	/0	0/186 (0.00%)	3/201 (1.49%)
Diarrhea † 1	/0	0/186 (0.00%)	11/201 (5.47%)
Mucositis oral † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Nausea † 1	/0	2/186 (1.08%)	1/201 (0.50%)
Vomiting † 1	/0	1/186 (0.54%)	0/201 (0.00%)
General disorders
Death NOS † 1	/0	1/186 (0.54%)	2/201 (1.00%)
Fatigue † 1	/0	4/186 (2.15%)	3/201 (1.49%)
General disorders and administration site conditions - Other † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Infections and infestations
Breast infection † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Catheter related infection † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Lung infection † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Sepsis † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Injury, poisoning and procedural complications
Wound complication † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Investigations
Alanine aminotransferase increased † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Aspartate aminotransferase increased † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Lymphocyte count decreased † 1	/0	2/186 (1.08%)	0/201 (0.00%)
Neutrophil count decreased † 1	/0	7/186 (3.76%)	1/201 (0.50%)
Platelet count decreased † 1	/0	14/186 (7.53%)	0/201 (0.00%)
White blood cell decreased † 1	/0	18/186 (9.68%)	5/201 (2.49%)
Metabolism and nutrition disorders
Hypokalemia † 1	/0	1/186 (0.54%)	1/201 (0.50%)
Nervous system disorders
Dizziness † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Headache † 1	/0	2/186 (1.08%)	0/201 (0.00%)
Peripheral sensory neuropathy † 1	/0	1/186 (0.54%)	1/201 (0.50%)
Syncope † 1	/0	0/186 (0.00%)	1/201 (0.50%)
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Hypoxia † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome † 1	/0	0/186 (0.00%)	10/201 (4.98%)
Vascular disorders
Hypertension † 1	/0	1/186 (0.54%)	0/201 (0.00%)
Thromboembolic event † 1	/0	0/186 (0.00%)	1/201 (0.50%)
1 Term from vocabulary, CTCAE 4.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Arm A (Observation)	Arm B (Cisplatin or Carboplatin)	Arm C (Capecitabine)
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/0	141/186 (75.81%)	165/201 (82.09%)
Blood and lymphatic system disorders
Anemia † 1	/0	102/186 (54.84%)	60/201 (29.85%)
Gastrointestinal disorders
Constipation † 1	/0	35/186 (18.82%)	22/201 (10.95%)
Diarrhea † 1	/0	12/186 (6.45%)	90/201 (44.78%)
Nausea † 1	/0	86/186 (46.24%)	80/201 (39.80%)
Vomiting † 1	/0	28/186 (15.05%)	24/201 (11.94%)
Investigations
White blood cell decreased † 1	/0	105/186 (56.45%)	50/201 (24.88%)
Nervous system disorders
Peripheral sensory neuropathy † 1	/0	47/186 (25.27%)	55/201 (27.36%)
Skin and subcutaneous tissue disorders
Alopecia † 1	/0	8/186 (4.30%)	11/201 (5.47%)
Palmar-plantar erythrodysesthesia syndrome † 1	/0	0/186 (0.00%)	113/201 (56.22%)
1 Term from vocabulary, CTCAE 4.0; † 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

• Name/Title: Study Statistician
• Organization: ECOG-ACRIN Cancer Research Group
• Phone: 16176323012
• EMail: eatrials@jimmy.harvard.edu

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

Mayer IA, Zhao F, Arteaga CL, Symmans WF, Park BH, Burnette BL, Tevaarwerk AJ, Garcia SF, Smith KL, Makower DF, Block M, Morley KA, Jani CR, Mescher C, Dewani SJ, Tawfik B, Flaum LE, Mayer EL, Sikov WM, Rodler ET, Wagner LI, DeMichele AM, Sparano JA, Wolff AC, Miller KD. Randomized Phase III Postoperative Trial of Platinum-Based Chemotherapy Versus Capecitabine in Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy: ECOG-ACRIN EA1131. J Clin Oncol. 2021 Aug 10;39(23):2539-2551. doi: 10.1200/JCO.21.00976. Epub 2021 Jun 6.

• Responsible Party: Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
• ClinicalTrials.gov Identifier: NCT02445391
• Other Study ID Numbers: EA1131; NCI-2014-01820 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); EA1131 ( Other Identifier: ECOG-ACRIN Cancer Research Group ); EA1131 ( Other Identifier: CTEP ); U10CA180820 ( U.S. NIH Grant/Contract ); U24CA196172 ( U.S. NIH Grant/Contract )
• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Results First Submitted: December 9, 2021
• Results First Posted: October 5, 2022
• Last Update Posted: July 10, 2023