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Study of Preoperative Chemotherapy for Early Triple Negative or HER2-positive Operable Breast Cancer

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ClinicalTrials.gov Identifier: NCT02934828
Recruitment Status : Unknown
Verified August 2016 by Pin Zhang, Chinese Academy of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : October 17, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Pin Zhang, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Neoadjuvant Chemotherapy Drug: postoperative chemotherapy Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : October 2014
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: 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.
Other Name: preoperative chemotherapy
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.
 Drug: postoperative chemotherapy
postoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on.
Other Name: Adjuvant Chemotherapy


Outcome Measures
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Primary Outcome Measures :
  1. Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Invasive breast cancer confirmed by pathology evaluation of core biopsy
  2. 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
  3. Female between18 to 70 years of age, Eastern Cooperative Oncology Group(ECOG) Performance Status 0 or 1
  4. 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
  5. Previously untreated
  6. Adequate hematologic function (absolute neutrophil count ≥ 1,500 cells/µL; hemoglobin > 9 g/dL, platelets > 100,000/µL.)
  7. 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:

  1. ICH:ER/PgR status positive
  2. HER2 positive breast cancer Patients with reduced ejection fraction <50% are not eligible
  3. Patients with second malignancies
  4. Patients with bilateral breast cancer
  5. allergic constitution
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02934828


Contacts
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Contact: Pin Zhang, professor 13701275563 Zhang_pin@sina.com

Locations
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China, Beijing
Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS) Recruiting
Beijing, Beijing, China, 100021
Contact: Pin ZHang, professor    13701275563    Zhang_pin@sina.com   
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
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Study Director: Pin Zhang, professor Chinese Academy of Medical Sciences (CAMS)
More Information
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Responsible Party: Pin Zhang, Professor, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT02934828     History of Changes
Other Study ID Numbers: LC2014A04
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
 Trastuzumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological