Clinical trial NCT00712881: Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
Official title: Prospective, Open-Label, Randomized Study of Combination Therapy of MYOCET® Plus Cyclophosphamide and Trastuzumab Versus Free Doxorubicin Plus Cyclophosphamide Alone, Each Followed by Docetaxel and Trastuzumab, in Neoadjuvant Setting in Treatment-Naive Patients With HER2-Positive Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-10
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast
timeFrame: At the end of Cycle 8 (each cycle length = 21 days)
Secondary outcomes:
measure: Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines
timeFrame: At the end of Cycle 8 (each cycle length = 21 days)
measure: Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF)
timeFrame: Baseline up to the end of Cycle 8 (each cycle length = 21 days)
measure: Change From Baseline in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Baseline, up to 5 years
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to the end of Cycle 8 (cycle length = 21 days)
measure: Percentage of Participants With Progression or Death
timeFrame: Up to 5 Years after randomization
measure: Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node
timeFrame: At the end of Cycle 8 (each cycle length = 21 days)
measure: Number of Participants Undergoing Breast Conservative Surgery
timeFrame: At the end of Cycle 8 (each cycle length = 21 days)
measure: Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
timeFrame: Up to Week 24
Other outcomes:
Locations:
city: Kufstein
country: Austria
facility: Teva Investigational Site 16
city: Wien
country: Austria
facility: Teva Investigational Site 15
city: Brussels
country: Belgium
facility: Teva Investigational Site 9
city: Yvoir
country: Belgium
facility: Teva Investigational Site 29
city: Clichy Cedex
country: France
facility: Teva Investigational Site 4
city: Nancy
country: France
facility: Teva Investigational Site 5
city: Reims
country: France
facility: Teva Investigational Site 33
city: Vandoeuvre-Les-Nancy CEDEX
country: France
facility: Teva Investigational Site 8
city: Aachen
country: Germany
facility: Teva Investigational Site 30
city: Dusseldorf
country: Germany
facility: Teva Investigational Site 11
city: Dusseldorf
country: Germany
facility: Teva Investigational Site 25
city: Essen
country: Germany
facility: Teva Investigational Site 32
city: Lorrach
country: Germany
facility: Teva Investigational Site 34
city: Munchen
country: Germany
facility: Teva Investigational Site 14
city: München
country: Germany
facility: Teva Investigational Site 27
city: Napoli
country: Italy
facility: Teva Investigational Site 20
city: Roma
country: Italy
facility: Teva Investigational Site 23
city: Verona
country: Italy
facility: Teva Investigational Site 21
city: Barcelona
country: Spain
facility: Teva Investigational Site 26
city: Barcelona
country: Spain
facility: Teva Investigational Site 3
city: Lleida
country: Spain
facility: Teva Investigational Site 1
city: Zaragoza
country: Spain
facility: Teva Investigational Site 2
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert
role: STUDY_DIRECTOR
References: