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-BE
- Lead Sponsor
- Schering Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 180
1) Subjects must demonstrate willingness to and be able to participate in the study and to adhere to dose and visit schedule;
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 or intermediate risk tumor characteristics:
- node-positive: T1-3, N1-2, M0;
- node-negative AND at least one of the following features: tumor > 2 cm in diameter, OR tumor > 1cm and negative ER/PR, OR malignancy grade II/III, OR presence of peritumoral vascular invasion OR age < 35 Y
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(s)).
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 10exp9/l, platelets = 100 x 10exp9/l and hemoglobin = LLN;
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
1) Clinical or radiological evidence of metastatic disease;
2) Prior radiotherapy, chemotherapy or biotherapy for the currently diagnosed breast cancer prior to randomization;
3) History of the following cancers:
?Ipsilateral breast cancer
?Invasive DCIS treated with any therapy other than excision
?Contralateral breast cancer
?History of non-breast malignancies witin the 5 years prior to study entry. Patients with the following cancers are eligible if diagnosed and treated within the previous 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin;
4) Clinically significant pericardial effusion;
5) 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)
6) Sensory/motor neuropathy > grade 2 as defined by NCI-CTC;
7) Pregnancy or intending to become pregnant during the study;
8) Nursing (breastfeeding) or intending to be nursing during the study;
9) 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
10) A situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study;
11) Is on staff, affiliated with,or a family member of the staff personnel directly involved with this study;
12) Usage of any investigational product within 30 days prior to enrollment;
13) Participation in any other interventional clinical study involving drug, device or biological. This would not prohibit the patient from participating in a QOL, questionnaire, blood collection, or observational study;
14) 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
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method