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

  • STATUS
    Recruiting
  • End date
    Dec 25, 2027
  • participants needed
    286
  • sponsor
    Chinese Academy of Medical Sciences
Updated on 25 January 2021
cancer
breast surgery
cyclophosphamide
breast cancer
HER2
adenocarcinoma
triple negative breast cancer
erbb2
taxane
epirubicin
adenocarcinoma of the breast
adjuvant chemotherapy

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.

Description

This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size1cm 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.

Details
Condition Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer
Treatment cyclophosphamide, Epirubicin or Pirarubicin
Clinical Study IdentifierNCT04437160
SponsorChinese Academy of Medical Sciences
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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)
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