NCT02934828

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
Completed

Started Oct 2014

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 17, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 18, 2016

Status Verified

August 1, 2016

Enrollment Period

3.2 years

First QC Date

August 14, 2016

Last Update Submit

October 15, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Recurrence-Free Survival (RFS) of neoadjuvant and adjuvant treatment in TNBC and her2 positive breast cancer

    5 years

Study Arms (2)

Neoadjuvant chemotherapy

EXPERIMENTAL

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

postoperative chemotherapy

ACTIVE COMPARATOR

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

Interventions

Neoadjuvant ChemotherapyDRUG

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.

Also known as: preoperative chemotherapy
Neoadjuvant chemotherapy
postoperative chemotherapyDRUG

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

Also known as: Adjuvant Chemotherapy
postoperative chemotherapy

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS)

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant TherapyChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Pin Zhang, professor

    Chinese Academy of Medical Sciences (CAMS)

    STUDY DIRECTOR

Central Study Contacts

Pin Zhang, professor

CONTACT

13701275563Zhang_pin@sina.com

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
Professor

Study Record Dates

First Submitted

August 14, 2016

First Posted

October 17, 2016

Study Start

October 1, 2014

Primary Completion

December 1, 2017

Study Completion

December 1, 2018

Last Updated

October 18, 2016

Record last verified: 2016-08

Locations

CN(1)