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

Primary Purpose

Triple Negative Breast Cancer

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Epirubicin or Pirarubicin

Cyclophosphamide

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Triple negative breast cancer, Neoadjuvant chemotherapy, Residual invasive breast cancer, Adjuvant chemotherapy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Adjuvant chemotherapy

Observation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

RFS

RFS defined as the time from randomization to the first recurrence event or death through the end of study

Secondary Outcome Measures

OS defined as the time from randomization to all-cause death through the end of study

Percentage of patients with adverse events

To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0

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

Full Information

NCT ID

NCT04437160

First Posted

June 5, 2020

Last Updated

June 16, 2020

Sponsor

Chinese Academy of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT04437160

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Recruiting

Study Start Date

February 1, 2020 (Actual)

Primary Completion Date

January 2026 (Anticipated)

Study Completion Date

December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chinese Academy of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Triple Negative Breast Cancer

Keywords

Triple negative breast cancer, Neoadjuvant chemotherapy, Residual invasive breast cancer, Adjuvant chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Adjuvant chemotherapy

Arm Type

Experimental

Arm Description

Arm Title

Observation

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Epirubicin or Pirarubicin

Other Intervention Name(s)

EPI or THP

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

CTX

Intervention Description

Cyclophosphamide 600mg/m2 IV, q21d*4cycls

Primary Outcome Measure Information:

Title

RFS

Description

RFS defined as the time from randomization to the first recurrence event or death through the end of study

Time Frame

median 5 years

Secondary Outcome Measure Information:

Title

Description

OS defined as the time from randomization to all-cause death through the end of study

Time Frame

median 5 years

Title

Percentage of patients with adverse events

Description

To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0

Time Frame

2-3 years

Title

Changes in patient-reported quality of life

Description

To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30

Time Frame

2-3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Pin ZHANG, MD

Phone

008601-87788120

Zhang_pin@sina.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pin ZHANG, MD

Organizational Affiliation

Chinese Academy of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100021

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pin ZHANG, MD

Phone

13701275563

Zhang_pin@sina.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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