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A Study of the Efficacy and Safety of Trastuzumab Emtansine (Trastuzumab-MCC-DM1) vs. Trastuzumab (Herceptin®) and Docetaxel (Taxotere®) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Trastuzumab emtansine [Kadcyla] (Drug); Trastuzumab (Drug); Docetaxel (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Hoffmann-La Roche

Official(s) and/or principal investigator(s):
Ellie Guardino, MD/PhD, Study Director, Affiliation: Genentech, Inc.

Summary

This was a Phase II, randomized, multicenter, international, 2-arm, open-label clinical trial designed to explore the efficacy and safety of trastuzumab emtansine (T-DM1) relative to the combination of trastuzumab and docetaxel in patients with human epidermal growth factor receptor 2 (HER2)-positive, unresectable, locally advanced breast cancer and/or metastatic breast cancer who have not received prior chemotherapy for metastatic disease.

Clinical Details

Official title: A Randomized, Multicenter, Phase ii Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 vs. Trastuzumab (Herceptin) and Docetaxel (Taxotere) in Patients With Metastatic HER2-positive Breast Cancer Who Have Not Received Prior Chemotherapy for Metastatic Disease

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression-free Survival (PFS) by the Investigator Using Modified Response Evaluation Criteria In Solid Tumors (RECIST)

Secondary outcome:

Overall Survival

Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Duration of Objective Response Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Clinical Benefit (CB) Assessed by the Investigator Using Response Evaluation Criteria in Solid Tumors (RECIST)

Time to Symptom Progression

Serum Concentrations (Area Under the Concentration-time Curve [AUC]) of Trastuzumab Emtansine and Total Trastuzumab

Plasma Concentration of Free Emtansine

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically or cytologically confirmed adenocarcinoma of the breast with locally

advanced or metastatic disease, and a candidate for chemotherapy.

- Human epidermal growth factor receptor 2 (HER2)-positive.

- No prior chemotherapy for their metastatic breast cancer (MBC).

- Measurable disease.

- Age ≥ 18 years.

- For women of childbearing potential and men with partners of childbearing potential,

agreement to use a highly effective, non-hormonal form of contraception or 2 effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the study. Exclusion Criteria:

- History of any chemotherapy for MBC.

- An interval of < 6 months from the completion of cytotoxic chemotherapy in the

neo-adjuvant or adjuvant setting until the time of metastatic diagnosis.

- Trastuzumab ≤ 21 days prior to randomization.

- Hormone therapy < 7 days prior to randomization.

- Current peripheral neuropathy of Grade ≥ 3.

- History of other malignancy within the last 5 years, except for appropriately treated

carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer, or other cancers with a similar outcome as those previously mentioned.

- Previous radiotherapy for the treatment of unresectable, locally advanced or

metastatic breast cancer is not allowed if more than 25% of marrow-bearing bone has been irradiated or the last fraction of radiotherapy has been administered within approximately 3 weeks prior to randomization.

- 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 2 months prior to randomization.

- History of exposure to the following cumulative doses of anthracyclines: Doxorubicin

or liposomal doxorubicin > 500 mg/m^2; epirubicin > 900 mg/m^2; mitoxantrone > 120mg/m^2 and idarubicin > 90 mg/m^2.

- Current unstable angina.

- History of symptomatic congestive heart failure, or ventricular arrhythmia requiring

treatment.

- History of myocardial infarction within 6 months prior to randomization.

- Left ventricular ejection fraction (LVEF) below 50% within approximately 28 days

prior to randomization.

- History of decreased LVEF or symptomatic congestive heart failure (CHF) with previous

adjuvant trastuzumab treatment.

- Cardiac troponin I ≥ 0. 2 ng/mL within 28 days of randomization.

- Severe dyspnea at rest because of complications of advanced malignancy or requiring

current continuous oxygen therapy.

- Current severe, uncontrolled systemic disease (eg, clinically significant

cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or bone fractures).

- Major surgical procedure or significant traumatic injury within approximately 28 days

prior to randomization or anticipation of the need for major surgery during the course of study treatment.

- Current pregnancy or lactation.

- History of receiving any investigational treatment within approximately 28 days prior

to randomization.

- Current known infection with human immunodeficiency virus (HIV), active hepatitis B

and/or hepatitis C virus.

- History of intolerance (including Grade 3-4 infusion reaction) or hypersensitivity to

trastuzumab, murine proteins, or docetaxel.

- Known hypersensitivity to any of the study drugs, including the excipients, or any

drugs formulated in polysorbate 80.

- Assessed by the investigator to be unable or unwilling to comply with the

requirements of the protocol.

Locations and Contacts

Additional Information

Starting date: September 2008
Last updated: December 9, 2013

Page last updated: August 23, 2015

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