Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer

Plain-language summary

This study evaluates MYOCET (liposomal doxorubicin) in combination with Cyclophosphamide, Trastuzumab, and Docetaxel in patients with HER2-positive Stage II or III breast cancer. It included treatment-naive patients with confirmed HER2 overexpression. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Cephalon, Inc.

Intervention

Liposomal doxorubicin hydrochloride, Cyclophosphamide, Trastuzumab, Free doxorubicin hydrochloride, Docetaxel

Start date

10/13/2008

Estimated completion

9/17/2015

Countries

Austria, Belgium, France, Germany, Italy, Spain

Related genes

Locations

• Kufstein, Austria
• Vienna, Austria
• Brussels, Belgium
• Yvoir, Belgium
• Clichy, France
• Nancy, France
• Reims, France
• Vandœuvre-lès-Nancy, France
• Aachen, Germany
• Düsseldorf, Germany
• Düsseldorf, Germany
• Essen, Germany
• Loerrach, Germany
• München, Germany
• München, Germany
• Naples, Italy
• Roma, Italy
• Verona, Italy
• Barcelona, Spain
• Barcelona, Spain
• Lleida, Spain
• Zaragoza, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Main Inclusion Criteria:

* Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2.
* Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria.
* The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The participant has an LVEF of at least 55% as assessed by multigated acquisition (MUGA) scan (preferred) or echocardiography.
* The participant has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
* Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.

Main Exclusion Criteria:

The participant:

* Has received previous cancer therapy for breast cancer.
* Has any history of CHF, angina pectoris, or myocardial infarction.
* Has uncontrolled hypertension.
* Has infection, peptic ulcer, or unstable diabetes mellitus.
* Has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
* Has impaired hepatic or renal function.
* Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
* Has used an investigational drug within one month before the screening visit.
* Has a known hypersensitivity to any of the study drugs or to their active ingredients.
* Has an inflammatory breast cancer.
* Has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).

Note: Other inclusion and exclusion criteria may apply.