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A Study of Pertuzumab in Combination With Herceptin and Chemotherapy 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:
NCT00976989
First received: September 14, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in patients with locally advanced, inflammatory or early stage HER2-positive breast cancer. Before surgery, patients will be randomized to receive either A) 6 cycles of pertuzumab plus Herceptin, with FEC (5-fluorouracil/epirubicin/cyclophosphamide) for cycles 1-3 and docetaxel for cycles 4-6, or B) FEC for cycles 1-3 followed by pertuzumab plus Herceptin with docetaxel for cycles 4-6, or C) 6 cycles of pertuzumab plus Herceptin with docetaxel and carboplatin. 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 iv 3-weekly, docetaxel at 75mg/m2 iv, increased to 100mg/m2 iv 3-weekly, and FEC and carboplatin iv 3-weekly at standard doses. Following surgery patients will receive Herceptin 6mg/kg iv 3-weekly for a total of 1 year, as well as adequate chemo-, radio- and hormone therapy. Anticipated time on study treatment is 4-12 months, and target sample size is 200-300.


Condition Intervention Phase
Breast Cancer
 Drug: pertuzumab
Drug: trastuzumab [Herceptin]
Drug: docetaxel
Drug: FEC: 5-Fluorouracil/epirubicin/cyclophosphamide
Drug: carboplatin
Drug: trastuzumab
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tolerability during neoadjuvant treatment: symptomatic cardiac events, LVEF [ Time Frame: throughout cycles 1-6, complete cardiac questionnaire every 3 weeks, LVEF cycles 2, 4 and 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pathological complete response rate [ Time Frame: at surgery, after 6 cycles of treatment ] [ Designated as safety issue: No ]
  • Safety: AEs, laboratory parameters, LVEF, ECG [ Time Frame: throughout study, laboratory parameters assessed every 3 weeks, LVEF and ECG every 2-3 cycles ] [ Designated as safety issue: No ]
  • Clinical response rate, time to response, disease-free survival, progression-free survival, overall survival [ Time Frame: throughout study, tumour assessment/breast examination every 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 225
Study Start Date: December 2009
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly, cycles 1-6
Drug: trastuzumab [Herceptin]
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly, cycles 1-6
Drug: docetaxel
75mg/m2 iv, escalated to 100mg/m2 iv 3-weekly, cycles 4-6
Drug: FEC: 5-Fluorouracil/epirubicin/cyclophosphamide
500mg/m2 5-Fluorouracil iv + 100mg/m2 epirubicin iv + 600mg/m2 cyclophosphamide iv 3-weekly, cycles 1-3
Drug: trastuzumab
post surgery, 6mg/m2 iv 3-weekly, cycles 7-20
Experimental: B Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly, cycles 4-6
Drug: trastuzumab [Herceptin]
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly, cycles 4-6
Drug: docetaxel
75mg/m2 iv, escalated to 100mg/m2 iv 3-weekly, cycles 4-6
Drug: FEC: 5-Fluorouracil/epirubicin/cyclophosphamide
500mg/m2 5-Fluorouracil iv + 100mg/m2 epirubicin iv + 600mg/m2 cyclophosphamide iv 3-weekly, cycles 1-3
Drug: trastuzumab
post surgery, 6mg/m2 iv 3-weekly, cycles 7-20
Experimental: C Drug: pertuzumab
840mg iv loading dose, followed by 420mg iv 3-weekly, cycles 1-6
Drug: trastuzumab [Herceptin]
8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly, cycles 1-6
Drug: docetaxel
75mg/m2 iv, escalated to 100mg/m2 iv 3-weekly, cycles 1-6
Drug: carboplatin
AUC6 (Calvert's Formula) 3-weekly, cycles 1-6
Drug: trastuzumab
post surgery, 6mg/m2 iv 3-weekly, cycles 7-20

  Eligibility

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

Inclusion Criteria:

  • female patients, age >/=18 years
  • advanced, inflammatory or early stage unilateral invasive breast cancer
  • HER2-positive breast cancer
  • baseline LVEF >/=55%

Exclusion Criteria:

  • metastatic disease (Stage IV) or bilateral breast cancer
  • previous anticancer therapy or radiotherapy for any malignancy
  • other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
  • clinically relevant cardiovascular disease
  • current chronic treatment with corticosteroids of >10mg methylprednisolone or equivalent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00976989

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00976989     History of Changes
Other Study ID Numbers: BO22280, 2009-012019-17
Study First Received: September 14, 2009
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Trastuzumab
Epirubicin
Carboplatin
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic

ClinicalTrials.gov processed this record on May 22, 2013