Last updated on October 2018

Platinum Based Chemotherapy or Capecitabine in Treating Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy


Brief description of study

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.

Detailed Study Description

PRIMARY OBJECTIVES:

I. To compare the invasive disease-free survival (IDFS) in triple-negative breast cancer (TNBC) patients with residual basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to capecitabine.

SECONDARY OBJECTIVES:

I. To evaluate overall survival (OS) and response-free survival (RFS) in the two arms in patients with TNBC with residual basal-like disease after neoadjuvant chemotherapy.

II. To characterize the side effects and tolerability of each platinum agent (cisplatin and carboplatin) as well as capecitabine in patients with TNBC with residual disease after neoadjuvant chemotherapy.

III. To identify the rate of basal-like gene expression using prediction analysis of microarray 50 (PAM50) analysis by digital messenger ribonucleic acid (mRNA) quantitation amongst drug-resistant residual TNBC after neoadjuvant chemotherapy.

IV. To compare the IDFS in TNBC patients with residual non-basal-like disease after neoadjuvant chemotherapy who are randomized to post-preoperative platinum based chemotherapy with those who are randomized to capecitabine (exploratory analysis).

V. To assess the difference in health-related quality of life (HRQL) between the platinum based and capecitabine chemotherapy arms.

VI. To describe the rate of neurotoxicity over time in the platinum arm, the rate of medication adherence in the capecitabine arm and the rates of amenorrhea in both arms (exploratory).

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A (closed to accrual 05/16/2016): Patients undergo observation.

ARM B: Patients receive cisplatin intravenously (IV) or carboplatin IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

ARM C: Patients receive capecitabine orally (PO) twice daily (BID) on days 1-14. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for up to 10 years.

Clinical Study Identifier: NCT02445391

Contact Investigators or Research Sites near you

Start Over

Michigan Cancer Specialists
Roseville, MI United States
  Connect »

Tareq Al Baghdadi

Advanced Breast Care Center PLLC
Warren, MI United States
2.44miles
  Connect »

Tareq Al Baghdadi

Bhadresh Nayak MD PC-Warren
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Great Lakes Cancer Management Specialists-Macomb Professional Building
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Macomb Hematology Oncology PC
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Michigan Breast Specialists-Warren
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Saint John Macomb-Oakland Hospital
Warren, MI United States
3.06miles
  Connect »

Tareq Al Baghdadi

Bhadresh Nayak MD PC-Sterling Heights
Sterling Heights, MI United States
5.05miles
  Connect »

Premier Hematology Oncology Care
Sterling Heights, MI United States
5.05miles
  Connect »

Tareq Al Baghdadi

Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Tareq Al Baghdadi

Lymphoma Clinic of Michigan
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Tareq Al Baghdadi

Michigan Breast Specialists-Grosse Pointe Woods
Grosse Pointe Woods, MI United States
5.61miles
  Connect »

Tareq Al Baghdadi

Ascension Saint John Hospital
Detroit, MI United States
5.61miles
  Connect »

Lawrence E. Flaherty

McLaren Cancer Institute-Macomb
Mount Clemens, MI United States
7.13miles
  Connect »

Ding Wang

Henry Ford Macomb Hospital-Clinton Township
Clinton Township, MI United States
8.18miles
  Connect »

William Beaumont Hospital-Grosse Point
Grosse Pointe, MI United States
8.23miles
  Connect »

Mitchell Folbe MD PC
Sterling Heights, MI United States
8.97miles
  Connect »

Tareq Al Baghdadi

Michigan Breast Specialists-Macomb Township
Macomb, MI United States
9.94miles
  Connect »

Tareq Al Baghdadi

Great Lakes Cancer Management Specialists-Macomb Medical Campus
Macomb, MI United States
9.94miles
  Connect »

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


Receive Emails About New Clinical Trials!

Sign up for our FREE service to receive email notifications when clinical trials are posted in the medical category of interest to you.