A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer

Breast Cancer Clinical Trial

Official title:

An Open-label, Multi-center Study of the Safety and Tolerability of the Combination of Trastuzumab-MCC-DM1 (T-DM1) With Docetaxel, and Potentially Pertuzumab, for Treatment for Patients With Advanced Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934856
• Other study ID #: BP22572
• Secondary ID: 2009-010000-28
• Status: Completed
• Phase: Phase 1
• First received: July 6, 2009
• Last updated: November 1, 2016
• Start date: July 2009
• Est. completion date: October 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This open-label, multi-center study will assess the safety and tolerability of adding trastuzumab emtansine (T-DM1) to docetaxel in patients with locally advanced or metastatic HER2-positive breast cancer. Patients will receive T-DM1 and docetaxel on Day 1 of each 3-week cycle. For patients with locally advanced breast cancer, pertuzumab may be added to trastuzumab emtansine and docetaxel. Anticipated time on study treatment is up to 6 cycles for patients with locally advanced breast cancer, until disease progression or unacceptable toxicity occurs for patients with metastatic breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• ECOG performance status 0-1 (ECOG performance status of 2 will be allowed if only due to debilitating bone disease)

• HER2-positive metastatic or locally advanced breast cancer

• For MBC (metastatic breast cancer) patients:

• documented metastatic or inoperable locally advanced (without meeting LABC criteria) disease, amenable for treatment with docetaxel

• history of disease progression within 3 months prior to study entry

• For LABC (locally advanced breast cancer) patients:

• newly diagnosed locally advanced breast cancer, Stage IIIA-IIIC (AJCC staging system)

Exclusion Criteria:

• Pregnant or lactating women

• Significant cardiac disease

• Inadequate bone marrow, liver or renal function

• For MBC patients:

• patients must not have received radiotherapy for the treatment of metastatic or locally recurrent/advanced disease other than for the relief of pain in progressing metastatic bone lesions and/or brain metastases

• brain metastases that are untreated, symptomatic or require therapy to control symptoms

• For LABC patients:

• clinically or radiologically detectable metastasis (M1 disease)

• patients for whom surgery as primary intent procedure is the best option to treat their disease

• previous systemic or loco regional anti-cancer therapy for locally advanced disease

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel
multiple doses
• pertuzumab
multiple doses
• trastuzumab emtansine
multiple doses

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  France,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicities		approximately 4 years	No
Primary	Safety: Incidence of adverse events		approximately 4 years	No
Secondary	Progression Free Survival (PFS), tumor assessments according to RECIST criteria		approximately 4 years	No
Secondary	Overall response rate		approximately 4 years	No
Secondary	Clinical benefit rate (complete response, partial response or stable disease for at least 6 months)		approximately 4 years	No
Secondary	Duration of response		approximately 4 years	No
Secondary	Time to treatment failure		approximately 4 years	No
Secondary	Pharmacokinetics: Area under the concentration-time curve (AUC)		Pre-dose and 15 min and 4 h post-dose Day 2 Cycle 1 and Day1 Cycles 2-5, end-of-infusion Day 8 Cycles 1-5	No