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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02934828
• Other study ID #: LC2014A04
• Status: Recruiting
• Phase: Phase 2
• First received: August 14, 2016
• Last updated: October 15, 2016
• Start date: October 2014
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Chinese Academy of Medical Sciences
• Contact: Pin Zhang, professor
• Phone: 13701275563
• Email: Zhang_pin[@]sina.com
• Is FDA regulated: No
• Health authority: China: Chinese Medical Association
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: December 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• postoperative chemotherapy
postoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH), EC/TC±H, and so on.

Locations

Country	Name	City	State
China	Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer		5 years	Yes