NCT01428414

Brief Summary

The purpose of the investigators study is to compare the efficacy and safety of combining trastuzumab and paclitaxel based regimen plus carboplatin or epirubicin as neoadjuvant therapy in Chinese HER2-positive breast cancer patients. 100 patients from multicenter would be randomly assigned into two treatment arms and receive neoadjuvant chemotherapy followed by operation and adjuvant treatment. The main end point of this study would be the efficacy and safety of the two treatment arms, and the trend of the two curves is anticipated.

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
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2011

Typical duration for phase_2

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

August 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

August 23, 2012

Status Verified

August 1, 2012

Enrollment Period

3 years

First QC Date

August 28, 2011

Last Update Submit

August 21, 2012

Conditions

HER-2 Positive Breast Cancer

Keywords

HER2Breast cancerneoadjuvant chemotherapyefficacysafety

Outcome Measures

Primary Outcomes (1)

  • pathologic complete response rate

    Percentage of complete pathological response, e.g. no microscopic evidence of residual invasive tumor cells in any resected specimens of the breast and/or axillary nodes.

    3 years

Secondary Outcomes (4)

  • Disease free survival

    3 years at most

  • Overall response rate

    3 years

  • Percentage of conserving breast surgery

    3 years

  • Safety

    3 years

Study Arms (2)

Trastuzumab+ Carboplatin+Paclitaxel

ACTIVE COMPARATOR

Neoadjuvant treatment regimen:Trastuzumab,Carboplatin,Paclitaxel

Drug: TrastuzumabDrug: PaclitaxelDrug: Carboplatin

Trastuzumab+Epirubicin+Paclitaxel

ACTIVE COMPARATOR

Neoadjuvant treatment regimen:Trastuzumab,Epirubicin,Paclitaxel

Drug: TrastuzumabDrug: PaclitaxelDrug: Epirubicin

Interventions

TrastuzumabDRUG

2 mg/kg, iv, d1,8,15(loading dose 4mg/kg wk1), qw

Also known as: Herceptin
Trastuzumab+ Carboplatin+PaclitaxelTrastuzumab+Epirubicin+Paclitaxel
PaclitaxelDRUG

75mg/m2, iv d1, 8,15. qw; 4-6 cycles

Also known as: Taxol
Trastuzumab+ Carboplatin+PaclitaxelTrastuzumab+Epirubicin+Paclitaxel
EpirubicinDRUG

75mg/m2, iv d1, q3w, 4-6 cycles

Also known as: Epirubicin Hydrochloride for Injection
Trastuzumab+Epirubicin+Paclitaxel
CarboplatinDRUG

AUC 2, qw, iv d1, 8,15. 4-6 cycles

Also known as: CARBOPLATIN FOR INJECTION
Trastuzumab+ Carboplatin+Paclitaxel

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients, presenting for the first time with invasive breast cancer, who have not received any previous treatment for an invasive malignancy
  • Aged ≥18 years and \< 70 years with life expectancy \> 12 months
  • Histologically confirmed invasive breast cancer (excluding inflammatory breast cancer) by core needle biopsy, staged II-III according to TNM Classification System, with no evidence of metastasis and tumor size ≥3 cm
  • HER2 positive confirmed by IHC 2+ and FISH positivity or IHC 3+
  • At least one measurable lesion according to RECIST criteria 1.1
  • Patients with a left ventricular ejection fraction(LVEF)≥55% by MUGA scan or echocardiography
  • ECOG PS 0-1
  • Willing to take biopsy before surgery and during chemotherapy and willing to take pre-operative chemotherapy and related treatment
  • Signed written informed consent; Able to comply with the protocol

You may not qualify if:

  • Patient is pregnant or lactating.
  • Women of child-bearing potential must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to take an adequate contraceptive measure
  • Previous treatment with chemotherapy or hormonal therapy or any prior therapy with an anti-HER2 therapy for any malignancy.
  • History of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction
  • Other invasive malignancy (including second primary breast cancer) which could affect compliance with the protocol or interpretation of results. Patients who have been curatively treated and free of malignant disease for greater than 5 years are generally eligible
  • Inadequate bone marrow, hepatic and renal functions as evidenced by the following:
  • Neutrophil count of \<1500/uL,
  • Platelet count of \<100,000/uL.
  • Haemoglobin \<10 g/dL.
  • Serum total bilirubin \> 1.5\*ULN (upper limit of normal),
  • ALT or AST \> 2.5\*ULN,
  • Alkaline phosphatase \> 2.5\*ULN,
  • Serum creatinine \> 1.5\*ULN.
  • Other serious illness or medical condition including:
  • Congestive heart failure (NYHA class II, III, IV) or history of documented congestive heart failure, unstable angina pectoris, myocardial infarction in the last 6 months, clinically significant valvular heart disease, or high-risk uncontrolled arrhythmias.
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (6)

  • Sikov WM, Dizon DS, Strenger R, Legare RD, Theall KP, Graves TA, Gass JS, Kennedy TA, Fenton MA. Frequent pathologic complete responses in aggressive stages II to III breast cancers with every-4-week carboplatin and weekly paclitaxel with or without trastuzumab: a Brown University Oncology Group Study. J Clin Oncol. 2009 Oct 1;27(28):4693-700. doi: 10.1200/JCO.2008.21.4163. Epub 2009 Aug 31.

    PMID: 19720916BACKGROUND

  • Chang HR. Trastuzumab-based neoadjuvant therapy in patients with HER2-positive breast cancer. Cancer. 2010 Jun 15;116(12):2856-67. doi: 10.1002/cncr.25120.

    PMID: 20564392BACKGROUND

  • Piccart-Gebhart MJ, Burzykowski T, Buyse M, Sledge G, Carmichael J, Luck HJ, Mackey JR, Nabholtz JM, Paridaens R, Biganzoli L, Jassem J, Bontenbal M, Bonneterre J, Chan S, Basaran GA, Therasse P. Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer. J Clin Oncol. 2008 Apr 20;26(12):1980-6. doi: 10.1200/JCO.2007.10.8399.

    PMID: 18421049BACKGROUND

  • Nistico C, Bria E, Cuppone F, Fornier M, Sperduti I, Carpino A, Pace A, Cognetti F, Terzoli E. Weekly epirubicin and paclitaxel with granulocyte colony-stimulating factor support in previously untreated metastatic breast cancer patients: a phase II study. Anticancer Drugs. 2007 Jul;18(6):687-92. doi: 10.1097/CAD.0b013e328035f863.

    PMID: 17762397BACKGROUND

  • Gianni L, Eiermann W, Semiglazov V, Manikhas A, Lluch A, Tjulandin S, Zambetti M, Vazquez F, Byakhow M, Lichinitser M, Climent MA, Ciruelos E, Ojeda B, Mansutti M, Bozhok A, Baronio R, Feyereislova A, Barton C, Valagussa P, Baselga J. Neoadjuvant chemotherapy with trastuzumab followed by adjuvant trastuzumab versus neoadjuvant chemotherapy alone, in patients with HER2-positive locally advanced breast cancer (the NOAH trial): a randomised controlled superiority trial with a parallel HER2-negative cohort. Lancet. 2010 Jan 30;375(9712):377-84. doi: 10.1016/S0140-6736(09)61964-4.

    PMID: 20113825BACKGROUND

  • Han S, Kim J, Lee J, Chang E, Gwak G, Cho H, Yang KH, Park S, Park K. Comparison of 6 cycles versus 4 cycles of neoadjuvant epirubicin plus docetaxel chemotherapy in stages II and III breast cancer. Eur J Surg Oncol. 2009 Jun;35(6):583-7. doi: 10.1016/j.ejso.2009.01.002. Epub 2009 Feb 5.

    PMID: 19195817BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

TrastuzumabPaclitaxelEpirubicinInjectionsCarboplatin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesDoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydratesDrug Administration RoutesDrug TherapyTherapeuticsCoordination Complexes

Study Officials

  • Zhi-Ming Shao, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor and director of department of the Breast Cancer Institute, Fudan University

Study Record Dates

First Submitted

August 28, 2011

First Posted

September 5, 2011

Study Start

August 1, 2011

Primary Completion

August 1, 2014

Study Completion

February 1, 2015

Last Updated

August 23, 2012

Record last verified: 2012-08

Locations

CN(1)