Phase 2
N=181
Phase II Trial to Compare the Safety of Two Chemotherapy Plus Trastuzumab Regimens as Adjuvant Therapy for HER2-positive Breast Cancer (Study P05048)
Breast Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00550771 ↗Enrolled (actual)
181
Serious AEs
15.1%
Results posted
Oct 2011
Primary outcome: Primary: 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 — 5; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- doxorubicin, cyclophosphamide, paclitaxel, trastuzumab (Drug); PLD, cyclophosphamide, trastuzumab, paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
5; 11 | — |
| SECONDARY Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During the 8 Cycles of Chemotherapy |
1; 0; 1; 3; 0; 0 | — |
| SECONDARY Number of Participants Who Experienced Cardiac Events (Level 1 or 2) or Inability to Administer Trastuzumab During 1 Year of Trastuzumab Therapy |
1; 0; 4; 10; 4; 8 | — |
| SECONDARY Number of Participants Who Survived Without Relapse |
— | — |
Summary
The purpose of this study is to compare the incidence of cardiac dysfunction in subjects with human epidermal growth factor receptor 2 (HER2) positive breast cancer treated with either doxorubicin or pegylated liposomal doxorubicin (PLD), both in combination with trastuzumab.
Eligibility Criteria
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 characteristics:
- 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 =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 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
Data sourced from ClinicalTrials.gov (NCT00550771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.