Clinical trial NCT00475670: A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
Official title: An Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by 3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
* metastatic breast cancer \>=12 months after discontinuation of Herceptin;
* measurable disease.

Exclusion Criteria:

* previous chemotherapy for metastatic breast cancer;
* brain metastases;
* invasive malignancy other than metastatic breast cancer.

Primary outcomes:
measure: Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) According to the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Guidelines
timeFrame: Baseline (BL); Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
Secondary outcomes:
measure: Duration of Response - Percentage of Participants With Progressive Disease or Death
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Duration of Response
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Progression-Free Survival
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Percentage of Participants With Treatment Failure
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Time to Treatment Failure
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Percentage of Participants With Clinical Benefit According to RECIST Guidelines
timeFrame: BL, Day 1 of Weeks 7, 13, 19, 25, 37, and 52, at the last administration of study treatment, every 24 weeks thereafter until disease progression for up to 6 months after the last participant was recruited
measure: Overall Survival - Percentage of Participants Who Died
timeFrame: BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 5 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment
measure: Overall Survival
timeFrame: BL, Day 1 of Weeks 1, 4, 7, 10, 13, 16, 19, 25, 37, and 52 at the last administration of study treatment, every 24 weeks thereafter until disease progression or death, yearly thereafter up to 2 years after cessation of recruitment
Other outcomes:
Locations:
city: Geelong
country: Australia
state: Victoria
city: Klagenfurt
country: Austria
city: Salzburg
country: Austria
city: Vöcklabruck
country: Austria
city: Wien
country: Austria
city: Brussel
country: Belgium
city: Namur
country: Belgium
city: Porto Alegre
country: Brazil
state: RS
city: Porto Alegre
country: Brazil
state: RS
city: Winnipeg
country: Canada
state: Manitoba
city: Brampton
country: Canada
state: Ontario
city: Oshawa
country: Canada
state: Ontario
city: Greenfield Park
country: Canada
state: Quebec
city: Beijing
country: China
city: Guangzhou
country: China
city: Shanghai
country: China
city: Wuhan
country: China
city: Berlin
country: Germany
city: Düsseldorf
country: Germany
city: Hamburg
country: Germany
city: Krefeld
country: Germany
city: Köln
country: Germany
city: Lemgo
country: Germany
city: München
country: Germany
city: Tübingen
country: Germany
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Kecskemet
country: Hungary
city: Szeged
country: Hungary
city: Chieti
country: Italy
city: Genova
country: Italy
city: Roma
country: Italy
city: San Giovanni Rotondo
country: Italy
city: Sassari
country: Italy
city: Merida
country: Mexico
city: Panama City
country: Panama
city: Gdansk
country: Poland
city: Gliwice
country: Poland
city: Lodz
country: Poland
city: Kazan
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: La Coruna
country: Spain
state: La Coruña
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Zaragoza
country: Spain
city: Changhua
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan
country: Taiwan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Lang I, Bell R, Feng FY, Lopez RI, Jassem J, Semiglazov V, Al-Sakaff N, Heinzmann D, Chang J. Trastuzumab retreatment after relapse on adjuvant trastuzumab therapy for human epidermal growth factor receptor 2-positive breast cancer: final results of the Retreatment after HErceptin Adjuvant trial. Clin Oncol (R Coll Radiol). 2014 Feb;26(2):81-9. doi: 10.1016/j.clon.2013.08.011. Epub 2013 Sep 17.