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

  • STATUS
    Recruiting
  • End date
    Dec 5, 2027
  • participants needed
    286
  • sponsor
    Chinese Academy of Medical Sciences
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Updated on 19 February 2024
See if I qualify
cancer
breast cancer
renal disease
taxane
cyclophosphamide
adenocarcinoma
breast surgery
triple negative breast cancer
adenocarcinoma of the breast
immunomodulators
epirubicin
residual tumor
adjuvant chemotherapy
adjuvant
HER2
tumor excision
triple negative breast neoplasms

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, Breast Cancer, Breast Cancer - HER2 Positive, Chronic Shoulder Pain
Age 18years - 75years
Treatment Cyclophosphamide, Epirubicin or Pirarubicin
Clinical Study IdentifierNCT04437160
SponsorChinese Academy of Medical Sciences
Last Modified on19 February 2024

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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cancer
breast cancer
renal disease
taxane
cyclophosphamide
adenocarcinoma
breast surgery
triple negative breast cancer
adenocarcinoma of the breast
immunomodulators
epirubicin
residual tumor
adjuvant chemotherapy
adjuvant
HER2
tumor excision
triple negative breast neoplasms

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