Randomized Phase II Multinational Trial to Evaluate the Safety of Two Chemotherapy plus Trastuzumab Regimens as Adjuvant Therapy in Patients with HER2-positive Breast Cancer: Caelyx + Cyclophosphamide + Trastuzumab (C+C+H) or Doxorubicin + Cyclophosphamide (A+C), Each Followed by Paclitaxel + Trastuzumab (T+H) BACH. - Phase II Randomized Adjuvant Caelyx + Herceptin in Breast Cancer

• Conditions: Investigate patients with operable, node-positive or high-risk node-negative HER2-positive Breast Carcinoma.

• Registration Number: EUCTR2006-005780-26-PT
• Lead Sponsor: Integrated Therapeutics Group Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-18
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

Subjects with operable, node-positive or high-risk node-negative (see #3 below) HER2-positive breast carcinoma are eligible for the study, provided they satisfy the following criteria.
1) Subjects must demonstrate willingness to and be able to participate in the study and to adhere to dose and visit schedules;
2) Subjects must be of female gender and =18 years of age;
3) Subjects must have been diagnosed with operable, histological confirmed adenocarcinoma of the breast with no clinical or radiological evidence of metastatic disease but with otherwise high risk tumor characteristics:
- node-positive: T1-3, N1-2, M0;
- node-negative: tumor > 2 cm in diameter and positive ER or PR, or tumor > 1cm and negative ER/PR- or malignancy grade II/III
4) HER2-positive by FISH (with gene amplification) or 3+ using immunohistochemistry
5) Subjects must have had complete resection (R0) of the primary tumor and axillary lymph nodes (or must have negative sentinel node).
6) Baseline LVEF by MUGA scan or echocardiogram (ECHO) = 55%.
7) ECOG-performance status of 0-1;
8) Adequate postoperative bone marrow function with neutrophils = 1.5 x 109/l, platelets = 100 x 109/l and hemoglobin = 7.5 mmol/l;
9) Adequate renal function: calculated creatinine clearance = 50 ml/min.
10) Adequate postoperative liver function with with a total bilirubin < ULN, alkaline phosphatase < 2.5 times the ULN and AST < 1.5 times the ULN;
11) Subjects must be free of any clinically relevant disease that would, in the principal investigator’s and/or sponsor’s opinion, interfere with the conduct of the study or study evaluations;
12) Subjects of childbearing potential (including women who are less than 1 year postmenopausal and will be sexually active during the study) must agree to use a medically accepted method of contraception, while receiving protocol-specified medication and for 30 days after stopping the medication or be surgically sterilized prior to screening.
13) Subjects must be able to provide written informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A subject who meets any of the following exclusion criteria will be disqualified from participation in the study:
1) Clinical or radiological evidence of metastatic disease;
2) Prior radiotherapy, chemotherapy or biotherapy for the currently diagnosed breast cancer prior to randomization;
3) Clinically significant pericardial effusion;
4) Serious cardiac illness including, but not confined to
?history of documented congestive heart failure
?history of any form of cardiomyopathy or active treatment for any form of cardiomyopathy
?history of angina pectoris or documented transmural myocardial infarction, or active angina pectoris requiring medication
?serious ventricular arrhythmias requiring medication or ICD therapy, uncontrolled supraventricular arrhythmias
?clinically significant valvular disease
?poorly controlled arterial hypertension (systolic BP > 180 mmHg, diastolic BP > 100 mmHg)
5) Sensory/motor neuropathy > grade 2 as defined by NCI-CTC;
6) Pregnancy, or intending to become pregnant during the study;
7) Nursing, or intending to be nursing during the study;
8) Any of the following clinical conditions:
?Chronic obstructive pulmonary disease, requiring chronic treatment
?Clinically significant active infections
?A history of a psychological illness of condition, preventing the subject to
understand the requirements of the study.
?Unstable regulation of diabetes mellitus
9) A situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study;
10) Usage of any investigational product within 30 days prior to enrollment;
11) Participation in any other clinical study;
12) Allergy to or sensitivity to the study drug or its excipients.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified