Phase 2
N=102
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00193037 ↗Enrolled (actual)
102
Serious AEs
39.2%
Results posted
Jul 2013
Primary outcome: Primary: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment — 28; 31 percentage of patients
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Liposomal Doxorubicin (Drug); Docetaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- SCRI Development Innovations, LLC
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment |
28; 31 | — |
| SECONDARY Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease. |
6.5; 5.5 | — |
Summary
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Eligibility Criteria
Inclusion Criteria
To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- Prior adjuvant/neoadjuvant treatment allowed
- Measurable disease
- Able to perform activities of daily living with minimal assistance
- Age 18 years or older
- Adequate bone marrow, liver and kidney function
- Normal heart function
- Written informed consent
Exclusion Criteria
You cannot participate in this study if any of the following apply to you:
- Pre-existing moderate peripheral neuropathy
- History of significant heart disease
- Meningeal metastases.
- Prior chemotherapy for metastatic breast cancer
- No measurable disease (including bone only, pleural effusions, etc.)
- Receiving Herceptin therapy.
- Women who are pregnant or lactating.
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Data sourced from ClinicalTrials.gov (NCT00193037). 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.