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

Launched by CHINESE ACADEMY OF MEDICAL SCIENCES · Jun 16, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a specific type of chemotherapy called anthracycline-based treatment for patients with triple negative breast cancer (TNBC) who still have some cancer left after receiving initial chemotherapy. The trial will compare this chemotherapy to simply watching and waiting to see how things progress. It's designed for adults aged 18 to 75 who have been diagnosed with invasive breast cancer and have undergone certain treatments that didn’t completely eliminate the disease.

To be eligible for this study, participants must have confirmed triple negative breast cancer, meaning their cancer does not have certain hormone receptors and is not HER2 positive. They should have already received at least four cycles of specific chemotherapy drugs (platinum and taxanes) before surgery, and there should still be some invasive cancer present after surgery. If you join this trial, you can expect close monitoring and support as researchers gather information on how well the chemotherapy works and its side effects. This trial is currently recruiting participants, so it’s a great opportunity for eligible patients to contribute to important research that could improve future treatments for TNBC.

Gender

ALL

Eligibility 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).