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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Taxotere; Drug: Xeloda; Drug: Herceptin

• Registration Number: NCT02748213
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or metastatic breast cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-02
• Primary Completion: 2006-03
• Study Completion: 2008-01
• Study First Submitted: 2016-04-20
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-22
• Results First Submitted: 2016-06-15
• Status Verified: 2016-09
• Results First Submitted QC: 2016-09-30
• Last Update Submitted: 2016-09-30
• Results First Posted: 2016-11-22
• Last Update Posted: 2016-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 225

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%

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herceptin + Taxotere	Taxotere	Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.
Herceptin + Taxotere	Herceptin	Participants will receive dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal.
Herceptin + Taxotere + Xeloda	Xeloda	Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
Herceptin + Taxotere + Xeloda	Taxotere	Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.
Herceptin + Taxotere + Xeloda	Herceptin	Participants will receive triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal.

Primary Outcome Measures

Name	Time	Method
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)	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)	Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a best overall response for CR or PR was reported. The exact 95% confidence interval (CI) for one-sample binomial was determined using the Pearson-Clopper method.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With Death or Disease Progression According to RECIST	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)	Tumor response was assessed by RECIST during the study. Disease progression or progressive disease (PD) was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. The percentage of participants who died or experienced PD was reported.
Percentage of Participants Who Died	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)	The percentage of participants who died from any cause was reported.
Progression-Free Survival (PFS) According to RECIST	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)	Tumor response was assessed by RECIST during the study. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-treatment sum LD, or the appearance of new lesions. PFS was defined as the time from start of treatment to the first event of death or PD. Participants without event at the time of analysis were censored at the latest date of last tumor assessment or last date in drug log. The median duration of PFS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Overall Survival (OS)	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)	OS was defined as the time from start of treatment to date of death for any reason. Participants who were alive at the time of analysis were censored at the latest date of last tumor assessment, last drug intake, or last follow-up information. The median duration of OS and corresponding 95% CI were estimated by Kaplan-Meier analysis and expressed in months.
Duration of Response (DOR) According to RECIST	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)	Tumor response was assessed by RECIST during the study. CR was defined as disappearance of all target and non-target lesions and normalization of tumor marker levels. PR was defined as ≥30% decrease in sum LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. DOR was defined as the time from first assessment of CR or PR until the first occurrence of documented PD, death, or withdrawal. The median DOR was reported and expressed in months.