Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast Cancer

Running, not enrolling · Phase 3

Conditions studied: Breast Adenocarcinoma, Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma

In brief

This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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 doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Key facts

Study ID

NCT02488967

Run by

NRG Oncology

People needed

782

Starts

2015-07-26

Expected to finish

2026-10-31

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must have signed and dated an institutional review board (IRB)-approved consent form that conforms to federal and institutional guidelines
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination
• All of the following staging criteria (according to the 7th edition of the American Joint Committee on Cancer [AJCC] Cancer Staging Manual) must be met:
• By pathologic evaluation, primary tumor must be pT1-3
• By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN2b, pN3a, or pN3b
• If pN0, pathological tumor must be greater than or equal to 3.0 cm
• The tumor must have been determined to be human epidermal growth factor receptor 2 (HER2)-negative as follows:
• Immunohistochemistry (IHC) 0-1+; or
• IHC 2+ and in situ hybridization (ISH) non-amplified with a ratio of HER2 to centromere enumerator probe 17 (CEP17) less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells; or
• ISH non-amplified with a ratio of HER2 to CEP17 less than 2.0, and if reported, average HER2 gene copy number less than 4 signals/cells
• The tumor must have estrogen receptor (ER)-and progesterone receptor (PgR)-status assessed using current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines; patients are eligible if the tumor staining meets one of the following criteria:
• ER-negative and PgR-negative by ASCO/CAP guidelines, OR
• ER or PgR stains are positive in 1-9% of cells and neither is positive in greater than or equal to 10% of cells.
• The patient must have undergone either a mastectomy (total, skin-sparing, or nipple-sparing) or lumpectomy
• For patients who undergo lumpectomy, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist; if pathologic examination demonstrates tumor at the line of resection, additional excisions may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
• For patients who undergo mastectomy, the margins must be free of residual gross tumor; (patients with microscopic positive margins are eligible as long as post-mastectomy radiation therapy [RT] of the chest wall will be administered)
• The patient must have completed one of the procedures for evaluation of pathologic nodal status listed below.
• Sentinel lymphadenectomy alone:
• If pathologic nodal staging based on sentinel lymphadenectomy is pN0 or pN1b;
• If pathologic nodal staging based on sentinel lymphadenectomy is pN1mi or pN1a and the patient has undergone breast conserving surgery (with planned breast radiotherapy), the primary tumor must be T1 or T2 by pathologic evaluation and the nodal involvement must be limited to 1 or 2 positive nodes
• Sentinel lymphadenectomy followed by removal of additional non-sentinel lymph nodes if the sentinel node (SN) is positive; or
• Axillary lymphadenectomy with or without SN isolation procedure
• The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 60 days
• Absolute neutrophil count (ANC) must be greater than or equal to1200/mm\^3

You may not qualify if…

• T4 tumors including inflammatory breast cancer
• Definitive clinical or radiologic evidence of metastatic disease; required imaging studies must have been performed within 90 days prior to randomization
• Synchronous or previous contralateral invasive breast cancer; (patients with synchronous and/or previous contralateral DCIS or LCIS are eligible)
• Any previous history of ipsilateral invasive breast cancer or ipsilateral DCIS; (patients with synchronous or previous ipsilateral LCIS are eligible)
• History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
• Previous therapy with anthracyclines or taxanes for any malignancy
• Chemotherapy administered for the currently diagnosed breast cancer prior to randomization
• Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
• Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:
• Active cardiac disease
• Angina pectoris that requires the current use of anti-anginal medication;
• Ventricular arrhythmias except for benign premature ventricular contractions;
• Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
• Conduction abnormality requiring a pacemaker;
• Valvular disease with documented compromise in cardiac function; or
• Symptomatic pericarditis
• History of cardiac disease
• Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricle (LV) function;
• History of documented congestive heart failure (CHF); or
• Documented cardiomyopathy
• Uncontrolled hypertension defined as sustained systolic blood pressure (BP) greater than 150 mmHg or diastolic BP greater than 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
• Active hepatitis B or hepatitis C with abnormal liver function tests
• Patients known to be human immunodeficiency virus (HIV) positive with a baseline cluster of differentiation (CD)4 count of less than 250 cells/mm\^3 or have a history of acquired immune deficiency syndrome (AIDS) indicator conditions
• Intrinsic lung disease resulting in dyspnea
• History of hospitalization in past 12 months for diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic nonketotic syndrome (HHNS)

Where it is running

• Southern Cancer Center PC-Providence — Mobile, Alabama, United States
• Southern Cancer Center PC-Springhill — Mobile, Alabama, United States
• Anchorage Associates in Radiation Medicine — Anchorage, Alaska, United States
• Anchorage Radiation Therapy Center — Anchorage, Alaska, United States
• Alaska Breast Care and Surgery LLC — Anchorage, Alaska, United States
• Alaska Oncology and Hematology LLC — Anchorage, Alaska, United States
• Alaska Regional Hospital — Anchorage, Alaska, United States
• Alaska Women's Cancer Care — Anchorage, Alaska, United States
• Anchorage Oncology Centre — Anchorage, Alaska, United States
• Katmai Oncology Group — Anchorage, Alaska, United States
• Providence Alaska Medical Center — Anchorage, Alaska, United States
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States
• Arizona Breast Cancer Specialists-Gilbert — Gilbert, Arizona, United States
• Virginia G Piper Cancer Care-Glendale — Glendale, Arizona, United States
• CTCA at Western Regional Medical Center — Goodyear, Arizona, United States
• Arizona Center for Cancer Care-Peoria — Peoria, Arizona, United States
• Arizona Oncology Associates-Biltmore Cancer Center — Phoenix, Arizona, United States
• Arizona Breast Cancer Specialists-Phoenix — Phoenix, Arizona, United States
• Arizona Oncology-Deer Valley Center — Phoenix, Arizona, United States
• Arizona Breast Cancer Specialists — Scottsdale, Arizona, United States
• Arizona Breast Cancer Specialists-Scottsdale — Scottsdale, Arizona, United States
• Oncogyne PC-Arizona Oncology — Scottsdale, Arizona, United States
• Virginia G Piper Cancer Care-Del Camino — Scottsdale, Arizona, United States
• Sedona Medical Center — Sedona, Arizona, United States
• Southern Cancer Center PC-Mobile — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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