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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 2
18 Years
Not Enrolling
Breast Neoplasm

Thank you

Trial Information

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

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.

- Subjects must demonstrate willingness to and be able to participate in the study
and to adhere to dose and visit schedules

- Subjects must be of female gender and >= 18 years of age

- Subjects must have been diagnosed with operable, histologically confirmed
adenocarcinoma of the breast with no clinical or radiological evidence of
metastatic disease but with otherwise high or intermediate risk tumor

- node-positive: T1-3, N1-2, M0 (level of T [tumor involvement], N [lymph
node involvement], & M [matastases]) OR

- node-negative AND at least one of the following features:

- Tumor >2 cm or

- Tumor >1 cm and

- Negative estrogen receptor/progesterone receptor (ER/PR) or

- Malignancy Grade 2-3 or

- Presence of peritumoral vascular invasion or

- Age <35 years

- HER2-positive by fluorescence in situ hybridization (FISH)(with gene
amplification) or 3+ using immunohistochemistry

- Subjects must have had complete resection (R0) of the primary tumor and axillary
lymph nodes (or must have negative sentinel node[s])

- Baseline left ventricular ejection fraction (LVEF) by multiple gated acquisition
(MUGA) scan or echocardiogram (ECHO) >=55%

- Easter Cooperative Oncology Group (ECOG)-performance status of 0-1

- Adequate postoperative bone marrow function with neutrophils >=1.5 x 10^9/l,
platelets >=100 x 10^9/l and hemoglobin >= lower limit of normal (LLN)

- Adequate renal function: calculated creatinine clearance >=50 ml/min

- Adequate postoperative liver function with a total bilirubin < upper limit of
normal (ULN), alkaline phosphatase <2.5 times the ULN and aspartate
aminotransferase (AST) <1.5 times the ULN

- 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

- Subjects of childbearing potential (including women who are less than one 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 (or as per local requirements) after stopping the
medication or be surgically sterilized prior to screening

- Subjects must be able to provide written informed consent

Exclusion Criteria:

- Subject who meets any of the following exclusion criteria will be disqualified from
participation in the study:

- Clinical or radiological evidence of metastatic disease

- Prior radiotherapy, chemotherapy or biotherapy for the currently diagnosed
breast cancer prior to randomization

- Clinically significant pericardial effusion

- 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

- history of angina pectoris or documented transmural myocardial infarction,
or active angina pectoris requiring medication

- serious ventricular arrhythmias requiring medication or implantable
cardioverter-defibrillator (ICD) therapy, uncontrolled supraventricular

- clinically significant valvular disease

- poorly controlled arterial hypertension (systolic blood pressure (BP) >180
mmHg, diastolic BP >100 mmHg)

- Sensory/motor neuropathy > grade 2 as defined by National Cancer Institure -
Common Toxicity Criteria (NCI-CTC)

- Pregnancy, or intending to become pregnant during the study

- Nursing (breastfeeding) or intending to be nursing during the study

- 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

- A situation or condition that, in the opinion of the investigator, may interfere
with optimal participation in the study

- Is on staff, affiliated with, or a family member of the staff personnel directly
involved with this study

- Usage of any investigational product within 30 days prior to enrollment

- Participation in any other interventional clinical study involving drug, device
or biological. This would not prohibit the patient from participating in a
quality of life (QOL), questionnaire, blood collection, or observational study.

- Allergy to or sensitivity to the study drug or its excipients

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants Who Experienced Cardiac Events (Level 1 or 2), or Inability to Administer Trastuzumab Either During the 8 Cycles of Chemotherapy or According to Package Insert for a Total Duration of 1 Year

Outcome Description:

Cardiac events defined as: Level 1: Cardiac death due to heart failure (HF), myocardial infarction or arrhythmia, or probable cardiac death defined as sudden, unexpected death within 24 hours of a definite or probable cardiac event, or severe symptomatic HF, concomitant with a left ventricular ejection fraction (LVEF) drop of >10 percentage points from baseline and to ≤50% LVEF Level 2: Asymptomatic systolic dysfunction or mildly symptomatic HF concomitant with an LVEF drop of >10 percentage points from baseline and to <50% LVEF; the LVEF drop was to have been confirmed within 3-4 weeks.

Outcome Time Frame:

8 cycles of chemotherapy and subsequently one year of planned trastuzumab treatment

Safety Issue:



Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Study ID:




Start Date:

July 2007

Completion Date:

August 2010

Related Keywords:

  • Breast Neoplasm
  • Breast Neoplasms
  • Neoplasms