Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer

NCT02041338 | Unknown Phase 2

• 1 other identifier: CH-BC-026
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

There are no standard neodjuvant regimens adapted according to the different subtypes of breast cancer. This is a phase 2, randomized study to evaluate several regimens in different subtypes of breast cancer.

Conditions

Breast Cancer; Neoadjuvant Chemotherapy

Outcome Measures

Primary Outcomes (1)

• pathological complete response(pCR) rate of breast and axilla after surgery

  pathological complete response(pCR) of breast and axilla after surgery means after operation, no invasive component can be found in both breast and axillary lymph nodes. The pCR rate is calculated by number of patients having pCR after sugery divided by number of patients receiving neoadjuvant chemotherapy.

  3 years

Secondary Outcomes (3)

• Disease free survival

  3years and 5years after operation

• Overall survival

  3 years and 5years after operation

• Adverse event

  during screening and treatment, withing 21 days after day 1 of last cycle

Study Arms (6)

Luminal subtype test

EXPERIMENTAL

Paclitaxel 175mg/m2, every 2 weeks as a cycle for 4-6 cycles

Drug: Paclitaxel

Luminal subtype control

ACTIVE COMPARATOR

Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles

Drug: Epirubicin and Paclitaxel

Her2 positive subtype test

EXPERIMENTAL

Paclitaxel 175mg/m2 plus carboplatin AUC 4 with or without trastuzumab every 2 weeks as a cycle for 4-6 cycles

Drug: Paclitaxel and carboplatin

Her2 positive subtype control

ACTIVE COMPARATOR

Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 with or without trastuzumab every 3 weeks as a cycle for 4-6 cycles

Drug: Epirubicin and Paclitaxel

Triple negative subtype test

EXPERIMENTAL

Paclitaxel 175mg/m2 plus carboplatin AUC 4 every 2 weeks as a cycle for 4-6 cycles

Drug: Paclitaxel and carboplatin

Triple negative subypte control

ACTIVE COMPARATOR

Epirubicin 75mg/m2 plus paclitaxel 175mg/m2 every 3 weeks as a cycle for 4-6 cycles

Drug: Epirubicin and Paclitaxel

Interventions

Paclitaxel and carboplatin DRUG

Her2 positive subtype test; Triple negative subtype test

Paclitaxel DRUG

Luminal subtype test

Epirubicin and Paclitaxel DRUG

Her2 positive subtype control; Luminal subtype control; Triple negative subypte control

Eligibility Criteria

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

You may qualify if:

• Stage IIa-IIIc breast cancer patients plan to receive neoadjuvant chemotherapy
• Patients have enough tissue sample to do IHC test for subtype classification
• Patients have at least one measurable lesion according to RECIST1.1
• KPS≥80
• No prior treatment for breast cancer
• Adequate bone marrow (neutrophil count ≥1500 ml and platelet count ≥100,000 ml), renal (serum creatinine \<1.5 times the upper limit of normal \[ULN\] or a creatinine clearance of ≥60 ml/minute), hepatic (total bilirubin ≤1.5 ULN; alanine aminotransferase, aspartate aminotransferase, and alkaline phosphatase ≤2.5 ULN), and cardiac function (assessed by electrocardiogram or thoracic radiography) were required.

You may not qualify if:

• Fertile women were excluded if pregnant or lactating or if they were not using adequate contraception.
• Previous chemotherapy for breast cancer.
• history of other serious illness (e.g. congestive heart failure, angina pectoris, uncontrolled hypertension or arrhythmia, clinically significant neurologic or psychiatric disorders, uncontrolled serious infection, AIDS), had an organ allograft, severe gastrointestinal disorder, or other neoplasias (except for in situ cervical cancer, non-melanoma skin cancer, or previous diagnosis of cancer with no evidence of disease for \>10 years).

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel; Carboplatin; Epirubicin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Binghe Xu, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Fan, MD

CONTACT

861087788114; fanyingfy@medmail.com.cn

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: MD, professor and Director of Department of Medical Oncology

Study Record Dates

• First Submitted: January 15, 2014
• First Posted: January 22, 2014
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 25, 2014

Record last verified: 2014-02

Locations

CN (1)