A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer

NCT00679211 | Completed Phase 2 Results

• 1 other identifier: TDM4374g
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

HER2-positive breast cancer; HER2; MBC; Trastuzumab emtansine

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Objective Response as Assessed Through Independent Radiologic Review

  Objective response was defined as a complete response (CR) or partial response (PR) determined on two consecutive occasions ≥ 4 weeks apart, assessed using Response Evaluation Criteria in Solid Tumors (RECIST). CR: the disappearance of all target lesions and all nontarget lesions and normalization of tumor marker level and no new lesions. PR: disappearance of all target lesions and persistence of ≥ 1 nontarget lesion(s) and/or the maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diameter of target lesions, and no new lesions or unequivocal progression of existing nontarget lesions. The primary data cut-off date was 17 September 2009 (approximately 6 months after the last patient was enrolled). The final efficacy analysis was performed using a data cut-off date of 1 January 2010 (approximately 9 months after the last patient was enrolled).

  From randomization until the primary analysis data cut-off date of September 2009 (6 months after last patient enrolled) and until the final efficacy analysis cut-off date of 1 January 2010 (approximately 9 months after the last patient enrolled).

Secondary Outcomes (7)

• Duration of Objective Response as Assessed Through Independent Radiologic Review

  From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.

• Progression-free Survival as Assessed Through Independent Radiologic Review

  From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.

• Percentage of Participants With Clinical Benefit Based on Independent Radiologic Review

  From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.

• Objective Response Based on Investigator Assessment

  From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.

• Progression-free Survival Based on Investigator Assessment

  From randomization until 1 January 2010, approximately 9 months after the last participant was enrolled.

Study Arms (1)

Trastuzumab emtansine

EXPERIMENTAL

Trastuzumab emtansine (T-DM1) was administered to participants at a dose of 3.6 mg/kg by intravenous (IV) infusion every 3 weeks until documented disease progression, unmanageable toxicity, or study termination.

Drug: Trastuzumab emtansine [Kadcyla]

Interventions

Trastuzumab emtansine [Kadcyla] DRUG

Intravenous repeating dose

Also known as: Trastuzumab-MCC-DM1, T-DM1

Trastuzumab emtansine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed study-specific Informed Consent Form(s)
• Age ≥ 18 years
• Histologically documented breast cancer
• HER2-positive disease
• Metastatic breast cancer
• Disease progression on the last chemotherapy regimen received in the metastatic setting
• Prior treatment with an anthracycline, trastuzumab, a taxane, lapatinib, and capecitabine in the neoadjuvant, adjuvant, locally advanced, or metastatic setting and prior treatment with at least two lines of therapy (a line of therapy can be a combination of two agents or single-agent chemotherapy) in the metastatic setting
• At least two lines of anti-HER2 therapy must have been given in the metastatic setting as monotherapy or combined with chemotherapy or hormonal therapy. The HER2-targeted agent can include trastuzumab, lapatinib, or an investigational agent with HER2-inhibitory activity.
• A minimum of 6 weeks of trastuzumab for the treatment of metastatic disease is required
• Patients must have had at least 14 days of exposure in the metastatic setting to lapatinib and capecitabine (given together or separately) unless they were intolerant of lapatinib and/or capecitabine

You may not qualify if:

• Chemotherapy ≤ 21 days before enrollment
• Trastuzumab ≤ 21 days before enrollment
• Hormone therapy ≤ 7 days before enrollment
• Granulocyte-stimulating agent \< 14 days before enrollment
• Investigational therapy ≤ 28 days before enrollment
• Previous radiotherapy for treatment of metastatic breast cancer ≤ 21 days before enrollment
• Brain metastases that are untreated, symptomatic, or require therapy to control symptoms; or any radiation, surgery, or other therapy to control symptoms from brain metastases within 3 months of the first study treatment
• History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to trastuzumab or murine proteins
• History of exposure to the following cumulative doses of anthracyclines: Doxorubicin or liposomal doxorubicin \> 500 mg/m\^2; Epirubicin \> 900 mg/m\^2; Mitoxantrone \> 120 mg/m\^2 and idarubicin \> 90 mg/m\^2
• Peripheral neuropathy of Grade ≥ 3 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v3.0
• History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
• Current unstable angina
• History of symptomatic congestive heart failure (CHF), or ventricular arrhythmia requiring treatment
• History of myocardial infarction within 6 months of enrollment
• Left ventricular ejection fraction (LVEF) \< 50% within 28 days of enrollment

Sponsors & Collaborators

• Genentech, Inc.: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ado-Trastuzumab Emtansine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Maytansine; Macrolides; Lactones; Organic Chemicals; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Trastuzumab; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Medical Communications
• Organization: Genentech, Inc.

800-821-8590

Study Officials

• Ellie Guardino, M.D., PhD.

  Genentech, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2008
• First Posted: May 16, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: April 1, 2011
• Last Updated: March 31, 2017
• Results First Posted: April 23, 2013

Record last verified: 2013-05