Triple Negative Breast Cancer
Conditions
Keywords
Triple negative breast cancer, Neoadjuvant chemotherapy, Residual invasive breast cancer, Adjuvant chemotherapy
Brief 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.
Detailed description
This study is a multi-center, randomized, phase II study. TNBC patients with residual invasive disease (invasive breast tumor size≥1cm 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.
Interventions
DRUGEpirubicin or Pirarubicin
Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\*4cycls
DRUGCyclophosphamide
Cyclophosphamide 600mg/m2 IV, q21d\*4cycls
Sponsors
Chinese Academy of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RFS | median 5 years | RFS defined as the time from randomization to the first recurrence event or death through the end of study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | median 5 years | OS defined as the time from randomization to all-cause death through the end of study |
| Percentage of patients with adverse events | 2-3 years | To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0 |
| Changes in patient-reported quality of life | 2-3 years | To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30 |
Countries
China
Contacts
Primary ContactPin ZHANG, MD
Outcome results
None listed