Chemotherapy for Triple Negative Breast Cancer Patients with Residual Disease
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
This study is testing if giving extra chemotherapy to women with triple negative breast cancer who still have cancer after initial treatment can help them do better than just watching and waiting.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | ChineseAMS |
| Drugs / interventions | chemotherapy, cyclophosphamide |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT04437160 on ClinicalTrials.gov |
What this trial studies
This multi-center, randomized phase II study evaluates the efficacy and safety of anthracycline-based adjuvant chemotherapy compared to observation in patients with triple negative breast cancer (TNBC) who have residual invasive disease after receiving neoadjuvant chemotherapy. A total of 286 patients with invasive breast tumors and/or positive axillary lymph nodes will be enrolled and randomly assigned to either the chemotherapy group or the observation group. Those in the chemotherapy group will receive a regimen of anthracycline combined with cyclophosphamide for four cycles, with follow-up assessments every 3-6 months to monitor for recurrences and deaths. Blood and tissue samples will also be collected for further testing.
Who should consider this trial
Good fit: Ideal candidates are patients with histologically confirmed triple negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy.
Not a fit: Patients who have not undergone adequate tumor excision or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and outcomes for patients with residual triple negative breast cancer after initial treatment.
How similar studies have performed: Other studies have shown promising results with anthracycline-based chemotherapy in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Beijing, Beijing Municipality
- Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS) — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Pin ZHANG, MD — Chinese Academy of Medical Sciences
- Study coordinator: Pin ZHANG, MD
- Email: Zhang_pin@sina.com
- Phone: 008601-87788120
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.