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

Sponsor

Chinese Academy of Medical Sciences (Other)

Overall Status

Recruiting

CT.gov ID

NCT04437160

Collaborator

(none)

286

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Triple Negative Breast Cancer	Drug: Epirubicin or Pirarubicin Drug: Cyclophosphamide	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

286 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 1, 2020

Anticipated Primary Completion Date :

Jan 1, 2026

Anticipated Study Completion Date :

Dec 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adjuvant chemotherapy Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy. Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles.	Drug: Epirubicin or Pirarubicin Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d4cycls Other Names: EPI or THP Drug: Cyclophosphamide* Cyclophosphamide 600mg/m2 IV, q21d*4cycls Other Names: CTX
No Intervention: Observation No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.

Arm

Intervention/Treatment

Experimental: Adjuvant chemotherapy

Adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy. Adjuvant chemotherapy regiments: Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV + Cyclophosphamide 600mg/m2 IV, q21d*4cycles.

Drug: Epirubicin or Pirarubicin

Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls

Other Names:

EPI or THP

Drug: Cyclophosphamide

Cyclophosphamide 600mg/m2 IV, q21d*4cycls

Other Names:

CTX

No Intervention: Observation

No adjuvant chemotherapy for triple negative breast cancer with residual invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after taxanes and platinum based neoadjuvant chemotherapy.

Outcome Measures

Primary Outcome Measures

RFS [median 5 years]
RFS defined as the time from randomization to the first recurrence event or death through the end of study

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).