Phase 2
N=126
Combination Therapy With MYOCET® (Doxorubicin HCL Liposome for Injection) in Participants With HER2-Positive Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00712881 ↗Enrolled (actual)
126
Serious AEs
31.2%
Results posted
Feb 2024
Primary outcome: Primary: Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast — 41.3; 54.0 percentage of participants — p=0.154
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liposomal doxorubicin hydrochloride (Drug); Cyclophosphamide (Drug); Trastuzumab (Drug); Free doxorubicin hydrochloride (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Cephalon, Inc.
- Primary completion
- Sep 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Exhibiting a Pathological Complete Response (pCR) in Breast |
41.3; 54.0 | 0.154 |
| SECONDARY Percentage of Participants Who Achieved an Objective Response (Complete Response [CR] or Partial Response [PR]), as Defined by World Health Organization (WHO) Guidelines |
77.8; 84.1 | — |
| SECONDARY Percentage of Participants With Class III or IV New York Health Association (NYHA) Congestive Heart Failure (CHF) |
0; 0 | — |
| SECONDARY Change From Baseline in Left Ventricular Ejection Fraction (LVEF) |
-1.5; -1.0; -0.8; -3.4; -1.6; -3.6 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
62; 63 | — |
| SECONDARY Percentage of Participants With Progression or Death |
11.1; 12.7; 88.9; 87.3 | — |
| SECONDARY Percentage of Participants Achieving a Pathological Complete Response (pCR) in Breast and Node |
38.1; 47.6 | — |
| SECONDARY Number of Participants Undergoing Breast Conservative Surgery |
7; 5; 33; 31; 23; 27 | — |
| SECONDARY Severity of Adverse Events as Characterized by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) |
2; 1; 9; 12; 19; 18 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00712881). 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.