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A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00545688
First received: October 16, 2007
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  Purpose

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Condition Intervention Phase
Breast Cancer
 Drug: pertuzumab
Drug: Herceptin
Drug: docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pathological complete response rate [ Time Frame: Post-surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free interval, PFS, breast-conserving surgery rate. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, LVEF [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 417
Study Start Date: December 2007
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Experimental: 2 Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Experimental: 3 Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Experimental: 4 Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients, >=18 years of age;
  • locally advanced, inflammatory or early stage invasive breast cancer;
  • HER2 positive (HER2+++ by IHC or FISH/CISH+).

Exclusion Criteria:

  • metastatic disease (Stage IV) or bilateral breast cancer;
  • previous anticancer therapy or radiotherapy for any malignancy;
  • other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
  • insulin-dependent diabetes;
  • clinically relevant cardiovascular disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545688

  Show 76 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00545688     History of Changes
Other Study ID Numbers: WO20697
Study First Received: October 16, 2007
Last Updated: October 10, 2012
Health Authority: Italy: AIFA (Agenzia Italiana Farmaco)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Docetaxel
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 17, 2012