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

NCT04437160 | Recruiting Phase 2

• 1 other identifier: LC2019L06
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• RFS

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

  median 5 years

Secondary Outcomes (3)

• OS

  median 5 years

• Percentage of patients with adverse events

  2-3 years

• Changes in patient-reported quality of life

  2-3 years

Study Arms (2)

Adjuvant chemotherapy

EXPERIMENTAL

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; Drug: Cyclophosphamide

Observation

NO INTERVENTION

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.

Interventions

Epirubicin or Pirarubicin DRUG

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

Also known as: EPI or THP

Adjuvant chemotherapy

Cyclophosphamide DRUG

Cyclophosphamide 600mg/m2 IV, q21d\*4cycls

Also known as: CTX

Adjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Epirubicin; pirarubicin; Cyclophosphamide

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Pin ZHANG, MD

  Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pin ZHANG, MD

CONTACT

008601-87788120; Zhang_pin@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 18, 2020
• Study Start: February 1, 2020
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)