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: August 26, 2014
Last verified: August 2014
  Purpose

This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatmen t 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-w eekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and doceta xel 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 an ticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

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


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: June 2006
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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: 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
Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Experimental: 3 Drug: Herceptin
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly
Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly
Experimental: 4 Drug: docetaxel
75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Drug: pertuzumab
840mg iv loading dose, followed by 420mg 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545688

  Show 77 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: August 26, 2014
Health Authority: Italy: AIFA (Agenzia Italiana Farmaco)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Trastuzumab
Pertuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014