A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer

NCT ID: NCT00475670

Last Updated: 2014-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-10-31
• Study Completion Date: 2012-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trastuzumab Monotherapy

Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenous (i.v.) on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose on Day 1, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.

Group Type: ACTIVE_COMPARATOR

Trastuzumab

Intervention Type: DRUG

4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.

Trastuzumab, Taxane

Participant received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by 2mg/kg i.v. weekly, or an initial loading dose of 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death; and concomitant taxane, which is either 100 milligrams per square meter (mg/m2) docetaxel i.v. every 3 weeks, or 75 mg/m2 weekly or 175 mg/m2 every 3 weeks paclitaxel for at least 18 weeks, or more at the discretion of the investigator.

Group Type: EXPERIMENTAL

Trastuzumab

Intervention Type: DRUG

4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.

Taxane (docetaxel or paclitaxel)

Intervention Type: DRUG

Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.

Interventions

Trastuzumab

4 mg/kg i.v. loading dose on Day 1, followed by 2 mg/kg i.v. weekly; or 8 mg/kg i.v. loading dose, followed by 6 mg/kg i.v. every 3 weeks until disease progression, unacceptable toxicity, withdrawal or death.

Intervention Type: DRUG

Taxane (docetaxel or paclitaxel)

Docetaxel 100 mg/m2 i.v. every 3 weeks, or paclitaxel administered in a dose of 75 mg/m2 i.v. weekly or 175 mg/m2 i.v. every 3 weeks for at least 18 weeks, or more at the discretion of the investigator. Choice of taxane at the discretion of the investigator. Taxane may be administered at the same time, or 24 hours after, administration of trastuzumab.

Intervention Type: DRUG

Other Intervention Names

Herceptin; Docetaxel; Paclitaxel

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Geelong, Victoria, Australia

Klagenfurt, , Austria

Salzburg, , Austria

Vienna, , Austria

Vöcklabruck, , Austria

Brussels, , Belgium

Namur, , Belgium

Porto Alegre, Rio Grande do Sul, Brazil

Porto Alegre, Rio Grande do Sul, Brazil

Winnipeg, Manitoba, Canada

Brampton, Ontario, Canada

Oshawa, Ontario, Canada

Greenfield Park, Quebec, Canada

Beijing, , China

Guangzhou, , China

Shanghai, , China

Wuhan, , China

Berlin, , Germany

Cologne, , Germany

Düsseldorf, , Germany

Hamburg, , Germany

Krefeld, , Germany

Lemgo, , Germany

München, , Germany

Tübingen, , Germany

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Kecskemét, , Hungary

Szeged, , Hungary

Chieti, , Italy

Genova, , Italy

Roma, , Italy

San Giovanni Rotondo, , Italy

Sassari, , Italy

Mérida, , Mexico

Panama City, , Panama

Gdansk, , Poland

Gliwice, , Poland

Lodz, , Poland

Kazan', , Russia

Moscow, , Russia

Saint Petersburg, , Russia

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Jaén, Jaen, Spain

A Coruña, La Coruña, Spain

Madrid, Madrid, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Zaragoza, Zaragoza, Spain

Changhua, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taipei, , Taiwan

Taoyuan District, , Taiwan

Countries

Australia; Austria; Belgium; Brazil; Canada; China; Germany; Hungary; Italy; Mexico; Panama; Poland; Russia; Spain; Taiwan

References

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.

Reference Type: DERIVED

PMID: 24051172 (View on PubMed)

Other Identifiers

WO17299

Identifier Type: -

Identifier Source: org_study_id