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A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel With or Without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
 
Region Sponsors
California - Northern
NRG Oncology
 
Acronym KP IRB No.
1225897
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • 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
 
Exclusion Criteria
  • 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

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex S Menter
Contact Information:
- Desiree S Goldstein
-CTPCollaborate@kp.org
-Central Valley-Manteca


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