Thinking of joining a study?

Register your interest

Become a volunteer?

NCT04437160 | RECRUITING | Triple Negative Breast Cancer

Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
Sponsor:

Chinese Academy of Medical Sciences

Information provided by (Responsible Party):

pin Zhang

Brief Summary:

This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.

Condition or disease

Triple Negative Breast Cancer

Intervention/treatment

Epirubicin or Pirarubicin

Cyclophosphamide

Phase

PHASE2

Detailed Description:

This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks after surgery. Patients in the chemotherapy group are given anthracycline combined with cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.

Study Type : INTERVENTIONAL
Estimated Enrollment : 286 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Randomised, Open-label Phase II Study to Evaluate the Efficacy and Safety of Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Platinum-based Neoadjuvant Chemotherapy
Actual Study Start Date : 2020-02-01
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2027-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patients with histologically confirmed invasive adenocarcinoma of the breast.
  • * Triple negative breast cancer: hormone receptor negative (ER \< 10% and PgR \< 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
  • * Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
  • * Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
  • * Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
  • * Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
  • * ECOG Performance Status: 0-1.
  • * Patients without severe heart, lung, liver and kidney disease.
  • * Adequate hematologic and end-organ function.
  • * No more than 6 weeks may elapse between definitive breast surgery and randomization.
Exclusion Criteria
  • * Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
  • * Previous neoadjuvant chemotherapy with platinum or taxanes alone.
  • * Patients have received other adjuvant therapy.
  • * Comprehensive medical examinations have revealed distant metastases before randomization.
  • * Patients who are not suitable for anthracycline evaluated by investigators.
  • * Prior history of other malignancy (except carcinoma in situ).
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy

Location Details

NCT04437160

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

China, Beijing

Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)

Beijing, Beijing, China, 100021