Breast CancerPhase 2NCT00475670
A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
A Phase 2 study testing Trastuzumab and Taxane (docetaxel or paclitaxel) in people with Breast Cancer, run by Hoffmann-La Roche at 57 sites in 15 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab and Taxane (docetaxel or paclitaxel)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 57 sitesin 15 countries
- Study dates
- Oct 2005to Jun 2012
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 10 months of Herceptin treatment for HER2-positive early breast cancer;
- metastatic breast cancer >=12 months after discontinuation of Herceptin;
- measurable disease.
Who cannot join
- previous chemotherapy for metastatic breast cancer;
- brain metastases;
- invasive malignancy other than metastatic breast cancer.
Trial locations and contacts
57 sites in 15 countries.
57 sites in 15 countries
Germany8 sites
Study site
Berlin, 12203
Study site
Cologne, 50931
Study site
Düsseldorf, 40225
Study site
Hamburg, 20246
Study site
Krefeld, 47805
Study site
Lemgo, 32657
Study site
München, 81675
Study site
Tübingen, 72076
Spain8 sites
Study site
A Coruña, La Coruña, 15009
Study site
Barcelona, Barcelona, 08035
Study site
Barcelona, Barcelona, 08036
Study site
Jaén, Jaen, 23007
Study site
Madrid, Madrid, 28041
Study site
Valencia, Valencia, 46009
Study site
Valencia, Valencia, 46010
Study site
Zaragoza, Zaragoza, 50009
Hungary6 sites
Study site
Budapest, 1031
Study site
Budapest, 1083
Study site
Budapest, 1122
Study site
Budapest, 1145
Study site
Kecskemét, 6000
Study site
Szeged, 6701
Italy5 sites
Study site
Chieti, 66100
Study site
Genova, 16132
Study site
Roma, 00168
Study site
San Giovanni Rotondo, 71013
Study site
Sassari, 07100
Taiwan5 sites
Study site
Changhua, 500
Study site
Taipei, 00112
Study site
Taipei, 100
Study site
Taipei
Study site
Taoyuan, 333
Austria4 sites
Study site
Klagenfurt, 9026
Study site
Salzburg, 5020
Study site
Vienna, 1090
Study site
Vöcklabruck, 4840
Canada4 sites
Study site
Brampton, Ontario, L6R 3J7
Study site
Greenfield Park, Quebec, J4V 2H1
Study site
Oshawa, Ontario, L1G 2B9
Study site
Winnipeg, Manitoba, R2H 2A6
China4 sites
Study site
Beijing, 100021
Study site
Guangzhou, 510060
Study site
Shanghai, 200032
Study site
Wuhan, 430030
Poland3 sites
Study site
Gdansk, 80-214
Study site
Gliwice, 44-101
Study site
Lodz, 94-306
Russia3 sites
Study site
Kazan', 420029
Study site
Moscow, 115478
Study site
Saint Petersburg, 197758
Brazil2 sites
Study site
Porto Alegre, Rio Grande do Sul, 90610-000
Study site
Porto Alegre, Rio Grande do Sul, 91350-200
About this study
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
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
- Being tested
- Trastuzumab, Taxane (docetaxel or paclitaxel)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called Herceptin
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)Drug
Also called Docetaxel, 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.
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab Monotherapy | Active comparator | 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. Receives: Drug: Trastuzumab |
| Trastuzumab, Taxane | Experimental | 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. Receives: Drug: Trastuzumab; Drug: Taxane (docetaxel or paclitaxel) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
CR was defined for target lesions (TLs) as the disappearance of all lesions, and for nontarget lesions (NTLs) as the disappearance of all nontarget nonmeasurable lesions. PR was defined for TLs as at least a 30 percent (%) decrease from baseline (BL) in the sum of longest diameter (SLD) of TLs. 95% confidence interval for one-sample binomial using Pearson-Clopper method.
Measured: 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 (9)
Duration of Response - Percentage of Participants With Progressive Disease or Death
Duration of response was defined as the time from first confirmed CR or PR until death or progressive disease (PD). For TLs, PD was defined as at least a 20% increase in the SLD of the TL, taking as reference the smallest SLD recorded since the beginning of treatment or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of one or more new lesions or unequivocal progression of existing non target non-measurable lesions. Participants were censored at the date of the last tumor assessment.
Measured: 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
Duration of Response
The time, in months, from when the response (CR or PR) was first noted until the date of documented PD, death, or withdrawal, whichever occurred first. Participants were censored at the date of the last tumor assessment.
Measured: 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
Progression-free Survival (PFS) - Percentage of Participants With Progressive Disease
PFS was defined as the time from day of first study drug infusion until death or PD. Participants were censored at the date of the last tumor assessment.
Measured: 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
Progression-Free Survival
The time, in months, from BL to PFS event.
Measured: 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
Percentage of Participants With Treatment Failure
Treatment failure was defined as the time from first study drug infusion to failure. Failure was defined as any of the following: PD, death, withdrawal due to adverse event (AE) or lab abnormality, or refusal of treatment. Participants were censored at the last date recorded in the case report form (CRF) or the date of withdrawal.
Measured: 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
Time to Treatment Failure
The time, in months, from BL to treatment failure.
Measured: 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
Percentage of Participants With Clinical Benefit According to RECIST Guidelines
Clinical benefit was defined as stable disease (SD) for 6 months or longer, or a confirmed overall response of CR or PR. For TLs, SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest SLD since the beginning of treatment. For NTLs, SD was synonymous with incomplete response and defined as the persistence of one or more NTLs and/or maintenance of tumor marker level above the normal limits.
Measured: 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
Overall Survival - Percentage of Participants Who Died
OS was defined as the time from the date of enrollment to the date of death due to any cause. Participants were censored at the last date recorded in the CRF.
Measured: 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
Overall Survival
The time, in months, from BL to death due to any cause.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startOct 2005
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475670
- Sponsor's protocol ID
- WO17299
- Status last verified
- Sep 2014
- First submitted
- 17 May 2007
- Last updated
- 15 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
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.
PubMed 24051172