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

Triple Negative Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04437160
• Other study ID #: LC2019L06
• Status: Recruiting
• Phase: Phase 2
• Start date: February 1, 2020
• Est. completion date: December 2027

Study information

• Verified date: June 2020
• Source: Chinese Academy of Medical Sciences
• Contact: Pin ZHANG, MD
• Phone: 008601-87788120
• Email: Zhang_pin[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 286
• Est. completion date: December 2027
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Epirubicin or Pirarubicin
Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls
• Cyclophosphamide
Cyclophosphamide 600mg/m2 IV, q21d*4cycls

Locations

Country	Name	City	State
China	Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	RFS	RFS defined as the time from randomization to the first recurrence event or death through the end of study	median 5 years
Secondary	OS	OS defined as the time from randomization to all-cause death through the end of study	median 5 years
Secondary	Percentage of patients with adverse events	To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0	2-3 years
Secondary	Changes in patient-reported quality of life	To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30	2-3 years