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

NCT ID: NCT00712881

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-13
• Study Completion Date: 2015-09-17

Brief Summary

To evaluate the efficacy and safety of treatment with MYOCET® (doxorubicin hydrochloride) in combination with cyclophosphamide and trastuzumab, 4 cycles, followed by docetaxel plus trastuzumab, 4 cycles, in women with stage II or III breast cancer whose tumour overexpresses the human epidermal growth factor receptor 2 (HER2) gene.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Doxorubicin (MYOCET) + Cyclophosphamide + Trastuzumab (MCH) and Docetaxel + Trastuzumab (TH)

Participants will receive MCH (liposomal doxorubicin hydrochloride \[60 milligrams {mg}/square meter {m\^2}\], cyclophosphamide (600 mg/m\^2), and trastuzumab (8 or 6 mg/kilogram {kg}), administered as intravenous (IV) infusion on Day 1 of each of 4 consecutive 21-day cycles. For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles. After 4 cycles of MCH, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[6 mg/kg\]).

Group Type: EXPERIMENTAL

Liposomal doxorubicin hydrochloride

Intervention Type: DRUG

Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered per dose and schedule specified in the arm description.

Trastuzumab

Intervention Type: DRUG

Trastuzumab will be administered per dose and schedule specified in the arm description.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered per dose and schedule specified in the arm description.

Doxorubicin (Anthracycline) + Cyclophosphamide (AC) and Docetaxel + Trastuzumab (TH)

Participants will receive AC (free doxorubicin hydrochloride \[60 mg/m\^2\] and cyclophosphamide \[600 mg/m\^2\]), administered as IV infusion on Day 1 of each of 4 consecutive 21-day cycles. After 4 cycles of AC, the treatment will be changed to 4 consecutive 21-day cycles of TH (docetaxel \[100 mg/m\^2\] and trastuzumab \[8 or 6 mg/kg\]). For the first cycle, the loading dose of trastuzumab will be 8 mg/kg; 6 mg/kg will be used for the remaining cycles.

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide will be administered per dose and schedule specified in the arm description.

Trastuzumab

Intervention Type: DRUG

Trastuzumab will be administered per dose and schedule specified in the arm description.

Free doxorubicin hydrochloride

Intervention Type: DRUG

Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.

Docetaxel

Intervention Type: DRUG

Docetaxel will be administered per dose and schedule specified in the arm description.

Interventions

Liposomal doxorubicin hydrochloride

Liposomal doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide will be administered per dose and schedule specified in the arm description.

Intervention Type: DRUG

Trastuzumab

Trastuzumab will be administered per dose and schedule specified in the arm description.

Intervention Type: DRUG

Free doxorubicin hydrochloride

Free doxorubicin hydrochloride will be administered per dose and schedule specified in the arm description.

Intervention Type: DRUG

Docetaxel

Docetaxel will be administered per dose and schedule specified in the arm description.

Intervention Type: DRUG

Other Intervention Names

Myocet®; Anthracycline

Eligibility Criteria

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.

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cephalon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 16

Kufstein, , Austria

Teva Investigational Site 15

Vienna, , Austria

Teva Investigational Site 9

Brussels, , Belgium

Teva Investigational Site 29

Yvoir, , Belgium

Teva Investigational Site 4

Clichy, , France

Teva Investigational Site 5

Nancy, , France

Teva Investigational Site 33

Reims, , France

Teva Investigational Site 8

Vandœuvre-lès-Nancy, , France

Teva Investigational Site 30

Aachen, , Germany

Teva Investigational Site 11

Düsseldorf, , Germany

Teva Investigational Site 25

Düsseldorf, , Germany

Teva Investigational Site 32

Essen, , Germany

Teva Investigational Site 34

Loerrach, , Germany

Teva Investigational Site 14

München, , Germany

Teva Investigational Site 27

München, , Germany

Teva Investigational Site 20

Napoli, , Italy

Teva Investigational Site 23

Roma, , Italy

Teva Investigational Site 21

Verona, , Italy

Teva Investigational Site 26

Barcelona, , Spain

Teva Investigational Site 3

Barcelona, , Spain

Teva Investigational Site 1

Lleida, , Spain

Teva Investigational Site 2

Zaragoza, , Spain

Countries

Austria; Belgium; France; Germany; Italy; Spain

Other Identifiers

2008-000709-12

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C19562/2037

Identifier Type: -

Identifier Source: org_study_id