Chemotherapy for Triple Negative Breast Cancer Patients with Residual Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.