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Study of Optimizing Neoadjuvant Regimens in Subtypes of Breast Cancer

NCT ID: NCT02041338

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Breast cancer is a heterogenous disease with at least 4 intrinsic subtypes including Luminal A, Luminal B, HER2 enriched, Basal-like and normal breast like. Different subtypes have different prognosis and treatment sensitivity. Thus, it would be more suitable to administer different chemo-regimen in different subtypes. This is especially true in neoadjuvant chemotherapy setting where no standard regimen has ever been established. Therefore, we designed this phase 2 randomized clinical trial to explore potential effective regimens in variable subtypes of breast cancer in neoadjuvant treatment. Patients were first classified into Luminal type, Her2 positive type and triple-negative type by immunohistochemistry exam of ER/PR/HER2 in core needle biopsy and then randomized to received either dose dense paclitaxel in Luminal type or dose dense paclitaxel plus carboplatin with or without trastuzumab in HER2 positive type or dose dense paclitaxel plus carboplatin in triple-negative type.The control groups in each subtype all receive paclitaxel plus epirubicin every 3 weeks. The duration of treatment is 4-6 cycles. Primary endpoint is the pathological CR rate in each subtypes. Secondary endpoints include disease free survival, objective response rate, safety. Tissue samples and blood samples will be collected at baseline and during treatment. There will be exploratory biomarkers analyses to identify predictive markers for efficacy in every subtypes.

Conditions

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Breast Cancer Neoadjuvant Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Luminal subtype test

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

Group Type EXPERIMENTAL

Paclitaxel

Intervention Type DRUG

Luminal subtype control

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

Group Type ACTIVE_COMPARATOR

Epirubicin and Paclitaxel

Intervention Type DRUG

Her2 positive subtype test

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

Group Type EXPERIMENTAL

Paclitaxel and carboplatin

Intervention Type DRUG

Her2 positive subtype control

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

Group Type ACTIVE_COMPARATOR

Epirubicin and Paclitaxel

Intervention Type DRUG

Triple negative subtype test

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

Group Type EXPERIMENTAL

Paclitaxel and carboplatin

Intervention Type DRUG

Triple negative subypte control

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

Group Type ACTIVE_COMPARATOR

Epirubicin and Paclitaxel

Intervention Type DRUG

Interventions

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Paclitaxel and carboplatin

Intervention Type DRUG

Paclitaxel

Intervention Type DRUG

Epirubicin and Paclitaxel

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Binghe Xu

MD, professor and Director of Department of Medical Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Binghe Xu, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ying Fan, MD

Role: CONTACT

[email protected]
861087788114

Facility Contacts

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Ying Fan, MD

Role: primary

[email protected]
861087788114

Other Identifiers

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CH-BC-026

Identifier Type: -

Identifier Source: org_study_id