Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer
A Randomized Study of Preoperative Chemotherapy or Postoperative Chemotherapy for Early Triple Negative or Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Operable Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Neoadjuvant Chemotherapy (NCT) is a standard treatment of patients who hope breast-conserving therapy (BCT) with locally advanced inoperable breast cancer or large tumor size. it is beneficial to degrading the tumor stage, increasing the rate of surgical resection or the BCT.People who are pathological complete response (pCR) after NCT have an improvement in disease-free survival (DFS) and overall survival (OS), as well as better prognosis. Currently, breast cancer are entering into the era of molecular classification. Different molecular subtype of breast cancer showed a significant difference in prognosis; triple negative breast cancer (TNBC) and Her2 positive breast cancer are clinically relevant terms referring to a specific subtype of breast cancer with high malignant characteristics, early recurrence and metastasis, but sensitive to primary chemotherapy, proportion of which are 15% and 20% respectively. A meta analysis shows that TNBC and her2 positive breast cancer have a higher pCR than Luminal A/B, and the increasing in pCR rate means improvement in survival.
The investigators previous study indicates that paclitaxel plus carboplatin with or without trastuzumab can improve pCR and prolong RFS in TNBC and her2 positive breast cancer Comparing to adjuvant chemotherapy.
The investigators research aim to explores the optimal comprehensive treatment for TNBC and her2 positive breast cancer by comparing the efficacy of neoadjuvant with that of adjuvant treatment in improvement of RFS.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Beijing
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Beijing, Beijing, China, 100021
- Recruiting
- Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)
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Contact:
- Pin ZHang, professor
- Phone Number: 13701275563
- Email: Zhang_pin@sina.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Invasive breast cancer confirmed by pathology evaluation of core biopsy
- Tumors must be ER/PgR status negative (immunohistochemistry（IHC） < 10%) and lack of HER2/neu overexpression or amplification as measured by local hospital pathology laboratory (IHC +/- fluorescence in situ hybridization (FISH) and IHC < 3+, and FISH < 2.2) as described in the NCCN Guidelines
- Female between18 to 70 years of age, Eastern Cooperative Oncology Group(ECOG) Performance Status 0 or 1
- Early-stage TNBC or HER2 positive breast cancer according to the American Joint Committee on Cancer (AJCC) Staging Manual Clinical Stage IIA or IIB, Stage IIIA operable breast cancer
- Previously untreated
- Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin > 9 g/dL, platelets > 100,000/µL.)
- Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥≥ 3.0 g/dL, alanine aminotransferase and aspartate aminotransferase ≤ 1.5 x ULN.
Exclusion Criteria:
- ICH:ER/PgR status positive
- HER2 positive breast cancer Patients with reduced ejection fraction <50% are not eligible
- Patients with second malignancies
- Patients with bilateral breast cancer
- allergic constitution
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Neoadjuvant chemotherapy
Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6.
HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year.
RECIST is used once every 2 cycles.
Patients will finish 6 cycles preoperative chemotherapy when CR/partial response(PR)/stable disease(SD) by RECIST without serious adverse events.
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Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6.
HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year.
Other Names:
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Active Comparator: postoperative chemotherapy
Postoperative Chemotherapy:Standard chemotherapy regiments according to risk of recurrence: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on.
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postoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer
Time Frame: 5 years
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5 years
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Collaborators and Investigators
Investigators
- Study Director: Pin Zhang, professor, Chinese Academy of Medical Sciences (CAMS)
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LC2014A04
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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