A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT02748213
• Date of registration: 20/04/2016
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
• Scientific title: An Open-Label, Randomized Phase II Study of Herceptin (Trastuzumab), Taxotere (Docetaxel), and Xeloda (Capecitabine) in Combination, Versus Herceptin (Trastuzumab) Plus Taxotere (Docetaxel), in Patients With Advanced and/or Metastatic Breast Cancers That Overexpress HER2
• Date of first enrolment: February 2002
• Target sample size: 225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02748213
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

Australia, Brazil, Canada, Costa Rica, Finland, France, Greece, Guatemala, Italy, Mexico, Panama, Poland, Spain, Sweden, United Kingdom

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Histologically confirmed, HER2-positive advanced and/or metastatic breast cancer not
amenable to curative therapy

- At least one measurable lesion according to RECIST

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Baseline left ventricular ejection fraction (LVEF) at least 50%

Exclusion Criteria:

- Pregnant, lactating, or women of childbearing potential who are not surgically sterile
or not willing to use adequate contraceptive methods

- Previous treatment with Herceptin or other anti-HER therapies, or any previous
chemotherapy for advanced or metastatic disease

- Past medical history significant for any cardiac or central nervous system (CNS)
disorders

- Poor hematologic, renal, or hepatic function

- Chronic corticosteroid therapy



Age minimum: 18 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Breast Cancer

Intervention(s)

Drug: Taxotere

Drug: Herceptin

Drug: Xeloda

Primary Outcome(s)

Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) According to Response Evaluation Criteria in Solid Tumors (RECIST) [Time Frame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)]

Secondary Outcome(s)

Percentage of Participants With Death or Disease Progression According to RECIST [Time Frame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)]

Overall Survival (OS) [Time Frame: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)]

Progression-Free Survival (PFS) According to RECIST [Time Frame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)]

Percentage of Participants Who Died [Time Frame: Continuously during treatment (up to 66 months) and at any time after treatment discontinuation until 18 months after last participant enrolled (up to 66 months overall)]

Duration of Response (DOR) According to RECIST [Time Frame: Tumor assessments at Baseline, then every 6 weeks until Cycle 8 (cycle length of 21 days), then every 12 weeks until progressive disease and/or one year after enrollment; thereafter according to routine clinical practice (up to 66 months overall)]

Secondary ID(s)

MO16419

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/11/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02748213