A Study to Compare Subcutaneous Versus Intravenous Administration of Herceptin (Trastuzumab) in Women With HER2-Positive Early Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00950300
First received: July 30, 2009
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

In this open-label multicenter trial patients with operable or locally advanced breast cancer will be randomized to pre-operative treatment with 8 cycles of che motherapy (docetaxel followed by 5-fluorouracil/epirubicin/cyclophosphamide) con current with either SC Herceptin or IV Herceptin. After surgery patients will re ceive a further 10 cycles of Herceptin SC or IV as per randomization to complete

1 year of treatment. After the end of study treatment patients will be followed for safety and efficacy for at least 5 years, or until disease recurrence, whic hever is earlier.


Condition Intervention Phase
Breast Cancer
Drug: trastuzumab [Herceptin]
Drug: docetaxel
Drug: 5-fluorouracil
Drug: epirubicin
Drug: cyclophosphamide
Phase 3

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 Pharmacokinetics, Efficacy and Safety of Subcutaneous (SC) Herceptin (Trastuzumab) With Intravenous (IV) Herceptin (Trastuzumab) Administered in Women With HER2-positive Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Trastuzumab serum concentrations, comparing sc versus iv administration [ Time Frame: throughout cycles 1 to 8 ] [ Designated as safety issue: No ]
  • Pathological complete response [ Time Frame: after surgery between cycles 8 and 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trastuzumab serum concentrations, comparing sc versus iv administration after surgery [ Time Frame: throughout cycles 9 to 13 ] [ Designated as safety issue: No ]
  • Total pathologic complete response [ Time Frame: after surgery between cycles 8 and 9 ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: after 2, 4, 6 and 8 cycles of treatment ] [ Designated as safety issue: No ]
  • Progression and recurrence free survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 6 years ] [ Designated as safety issue: No ]
  • Immunogenicity (formation of anti-trastuzumab antibodies) [ Time Frame: 6 years ] [ Designated as safety issue: No ]

Enrollment: 596
Study Start Date: October 2009
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC Drug: trastuzumab [Herceptin]
administered sc, day 1 of each 3-week cycle, 18 cycles
Drug: docetaxel
75 mg/sqm iv every 3 weeks, cycles 1 - 4
Drug: 5-fluorouracil
500 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: epirubicin
75 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: cyclophosphamide
500 mg/sqm iv every 3 weeks, cycles 5 - 8
Active Comparator: IV Drug: trastuzumab [Herceptin]
administered iv, day 1 of each 3-week cycle, 18 cycles
Drug: docetaxel
75 mg/sqm iv every 3 weeks, cycles 1 - 4
Drug: 5-fluorouracil
500 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: epirubicin
75 mg/sqm iv every 3 weeks, cycles 5 - 8
Drug: cyclophosphamide
500 mg/sqm iv every 3 weeks, cycles 5 - 8

  Eligibility

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

Inclusion Criteria:

  • Adult women >/= 18 years of age
  • Non-metastatic primary invasive adenocarcinoma of the breast clinical stage I-IIIC, including inflammatory and multicentric breast cancer, tumour size >/= 1 cm, histologically confirmed, HER2-positive
  • At least 1 measurable lesion in breast or lymph nodes according to RECIST v1.0 criteria, except for inflammatory carcinoma
  • Baseline LVEF >/= 55%

Exclusion Criteria:

  • History of any prior (ipsi- and/or contralateral) invasive breast carcinoma
  • Past or current history of malignant neoplasms, except for curatively treated basal and squamous cell carcinoma of the skin and in situ carcinoma of the cervix
  • Metastatic disease
  • Any prior therapy with anthracyclines
  • Prior anti-HER2 therapy or biologic or immunotherapy
  • Serious cardiac illness
  • Pregnant or lactating women
  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: NCT00950300

  Show 102 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: NCT00950300     History of Changes
Other Study ID Numbers: BO22227, 2008-007326-19
Study First Received: July 30, 2009
Last Updated: July 14, 2014
Health Authority: Hong Kong: Department of Health

Additional relevant MeSH terms:
Trastuzumab
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Fluorouracil
Docetaxel
Epirubicin
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 July 26, 2014