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

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 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.

Study Overview

• Status: Recruiting
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: Epirubicin or Pirarubicin; Drug: Cyclophosphamide

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 Type: Interventional
• Enrollment (Anticipated): 286
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pin ZHANG, MD; Phone Number: 008601-87788120; Email: Zhang_pin@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
      • Contact: Pin ZHANG, MD; Phone Number: 13701275563; Email: Zhang_pin@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RFS	RFS defined as the time from randomization to the first recurrence event or death through the end of study	median 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS defined as the time from randomization to all-cause death through the end of study	median 5 years
Percentage of patients with adverse events	To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0	2-3 years
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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Pin ZHANG, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2020
• Primary Completion (ANTICIPATED): January 1, 2026
• Study Completion (ANTICIPATED): December 1, 2027

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 16, 2020
• First Posted (ACTUAL): June 18, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 18, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Adjuvant chemotherapy; Neoadjuvant chemotherapy; Residual invasive breast cancer; Triple negative breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Epirubicin; Pirarubicin
• Other Study ID Numbers: LC2019L06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No