NCT02445391

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

Active, enrolled Phase 3 Results posted Last updated 1 April 2026

What this trial tests

Phase 3 trial testing Capecitabine in Estrogen Receptor Negative in 415 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

20 October 2015

Primary endpoint
7 April 2021

29 March 2031

Quick facts

Lead sponsor	ECOG-ACRIN Cancer Research Group
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	415
Start date	20 October 2015
Primary completion	7 April 2021
Estimated completion	29 March 2031
Sites	1024 locations across South Africa, United States

Drugs / interventions tested

• Capecitabine (capecitabine) — full drug profile →
• Carboplatin (Carboplatin) — full drug profile →
• Cisplatin (cisplatin) — full drug profile →

Conditions studied

• Estrogen Receptor Negative — all drugs for Estrogen Receptor Negative →
• HER2/Neu Negative — all drugs for HER2/Neu Negative →
• Invasive Breast Carcinoma — all drugs for Invasive Breast Carcinoma →
• Progesterone Receptor Negative — all drugs for Progesterone Receptor Negative →

Sponsor

ECOG-ACRIN Cancer Research Group

Who can join

18 and older, any sex, with Estrogen Receptor Negative or HER2/Neu Negative. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

3-year Invasive Disease-Free Survival (IDFS) Rate in Basal-Subtype Patients Primary · 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.

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.

Group	Value	95% CI
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)	42.0	30.5 – 53.1
Arm C (Capecitabine) (Open to Accrual 6/22/2016)	49.4	39.0 – 59.0

3-year Recurrence-Free Survival (RFS) Rate in Basal-Subtype Patients Secondary · 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.

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.

Group	Value	95% CI
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)	46.2	34.7 – 57.0
Arm C (Capecitabine) (Open to Accrual 6/22/2016)	49.3	38.9 – 58.9

3-year Overall Survival (OS) Rate in Basal-Subtype Patients Secondary · Assessed every 3 months within 2 years from randomization, every 6 months if 2-3 years

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.

Group	Value	95% CI
Arm B (Cisplatin or Carboplatin) (Enrolled While Arm C Was Open)	57.8	45.2 – 68.4
Arm C (Capecitabine) (Open to Accrual 6/22/2016)	66.2	56.3 – 74.3

Proportion of Basal Subtype Secondary · Assessed at registration to step 0 (baseline)

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.

Group	Value	95% CI
All Patients Concurrently Randomized to Arms B and C	78	73 – 82

Health-related Quality of Life (HRQL) at 6-month Assessment Secondary · Assessed at 6 months after randomization

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.

Group	Value	95% CI
Arm B (Cisplatin or Carboplatin)	14.7	± 1.8
Arm C (Capecitabine) (Open to Accrual 6/22/2016)	14.6	± 1.7

Health-related Quality of Life (HRQL) at 15-month Assessment Secondary · Assessed at 15 months after randomization

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.

Group	Value	95% CI
Arm B (Cisplatin or Carboplatin)	14.5	± 2.3
Arm C (Capecitabine) (Open to Accrual 6/22/2016)	14.9	± 1.8

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Arm A (Observation)

Serious: 0

Deaths: 2/3

Arm B (Cisplatin or Carboplatin)

Serious: 50/186 (27%)

Deaths: 51/199

Arm C (Capecitabine)

Serious: 32/201 (16%)

Deaths: 45/213

Serious adverse events (35 terms)

Reaction	System	Arm A (Observation)	Arm B (Cisplatin or Carbop…	Arm C (Capecitabine)
White blood cell decreased	Investigations	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Platelet count decreased	Investigations	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—
Neutrophil count decreased	Investigations	—	—	—
Fatigue	General disorders	—	—	—
Colitis	Gastrointestinal disorders	—	—	—
Death NOS	General disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Lymphocyte count decreased	Investigations	—	—	—
Headache	Nervous system disorders	—	—	—
Hearing impaired	Ear and labyrinth disorders	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—
Thrombotic thrombocytopenic purpura	Blood and lymphatic system disorders	—	—	—
Blood and lymphatic system disorders - Other, specify	Blood and lymphatic system disorders	—	—	—
Cardiac disorders - Other, specify	Cardiac disorders	—	—	—
General disorders and administration site conditions - Other	General disorders	—	—	—
Mucositis oral	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Breast infection	Infections and infestations	—	—	—
Catheter related infection	Infections and infestations	—	—	—
Lung infection	Infections and infestations	—	—	—
Sepsis	Infections and infestations	—	—	—
Wound complication	Injury, poisoning and procedural complications	—	—	—

Other adverse events (9 terms — click to expand)

Reaction	System	Arm A (Observation)	Arm B (Cisplatin or Carbop…	Arm C (Capecitabine)
Palmar-plantar erythrodysesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—
White blood cell decreased	Investigations	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—
Diarrhea	Gastrointestinal disorders	—	—	—
Nausea	Gastrointestinal disorders	—	—	—
Peripheral sensory neuropathy	Nervous system disorders	—	—	—
Constipation	Gastrointestinal disorders	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—

Most-reported serious reactions: White blood cell decreased, Anemia, Platelet count decreased, Diarrhea, Palmar-plantar erythrodysesthesia syndrome, Neutrophil count decreased, Fatigue, Colitis.

Data from ClinicalTrials.gov NCT02445391 adverse events section.

Sponsor's own description

This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Triple-negative breast cancer: treatment challenges and solutions.
   Collignon J, Lousberg L, Schroeder H, Jerusalem G. · · 2016 · cited 246× · PMID 27284266 · DOI 10.2147/bctt.s69488
2. Biology and Management of Patients With Triple-Negative Breast Cancer.
   Sharma P. · · 2016 · cited 198× · PMID 27401886 · DOI 10.1634/theoncologist.2016-0067
3. 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.
   Mayer IA, Zhao F, Arteaga CL, Symmans WF, et al · · 2021 · cited 110× · PMID 34092112 · DOI 10.1200/jco.21.00976
4. Efficacy of Neoadjuvant Carboplatin plus Docetaxel in Triple-Negative Breast Cancer: Combined Analysis of Two Cohorts.
   Sharma P, López-Tarruella S, García-Saenz JA, Ward C, et al · · 2017 · cited 108× · PMID 27301700 · DOI 10.1158/1078-0432.ccr-16-0162
5. What Is Known about Breast Cancer in Young Women?
   Zhu JW, Charkhchi P, Adekunte S, Akbari MR. · · 2023 · cited 90× · PMID 36980802 · DOI 10.3390/cancers15061917
6. Tumor-Infiltrating Lymphocytes and PD-L1 Expression in Pre- and Posttreatment Breast Cancers in the SWOG S0800 Phase II Neoadjuvant Chemotherapy Trial.
   Pelekanou V, Barlow WE, Nahleh ZA, Wasserman B, et al · · 2018 · cited 66× · PMID 29588392 · DOI 10.1158/1535-7163.mct-17-1005
7. TBCRC 030: a phase II study of preoperative cisplatin versus paclitaxel in triple-negative breast cancer: evaluating the homologous recombination deficiency (HRD) biomarker.
   Mayer EL, Abramson V, Jankowitz R, Falkson C, et al · · 2020 · cited 63× · PMID 32798689 · DOI 10.1016/j.annonc.2020.08.2064
8. Early Triple Negative Breast Cancer: Conventional Treatment and Emerging Therapeutic Landscapes.
   Diana A, Carlino F, Franzese E, Oikonomidou O, et al · · 2020 · cited 62× · PMID 32235297 · DOI 10.3390/cancers12040819