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Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Tumors, Breast Tumor

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Trial Information

Phase II, Multicenter, Open-label, Clinical Trial of Trabectedin (Yondelis) in Metastatic Breast Cancer Patients With Triple Negative Profile (ER-, PR-, HER2-), HER2 Overexpressing Tumors and BRCA1 or BRCA2 Mutation Carriers


This is an open-label, clinical trial evaluating the effectiveness and safety of trabectedin
in three subpopulations of breast cancer patients: Group A: triple negative profile (ER-,
PR-, HER-2-), Group B: human epidermal growth factor receptor-2 overexpressing tumors
(HER-2+) and Group C: familial BRCA1 or BRCA2 mutation carrier. Each subtype is defined
according to the estrogen, progesterone, and the Human Epidermal Growth Factor Receptor- 2
(HER-2) status in the primary tumor (present or overexpressing = positive or absent or do
not overexpressing = negative) or the history of having BRCA1 or BRCA2 mutation genes.
Trabectedin will be administered intravenously (iv) every three weeks. Patients will be
assessed weekly physical exam and / or laboratory testing. Radiological examination will
occur every 6 weeks to evaluate the patient's disease. Treatment will continue as long as
the patient tolerating trabectedin and their disease is stable or improving. Duration of
response, progression free-survival, exploratory evaluation of changes in tumor volume and
changes in tumoral radiological density, safety profile and exploratory,
hypothesis-generating pharmacoecogenomic analyses will be assessed.Patients are evaluable
for safety if they received at least part of one infusion of trabectedin. Safety will be
assessed by adverse events, laboratory measurements, and clinical examinations Trabectedin
will be administered intravenously (iv) at a dose of 1.3 mg/m2 over 3-hours (hrs) on Day 1
of every 21-day treatment cycle. In addition, patients will be administered dexamethasone on
Day 1 of each treatment cycle as follows: 4mg orally (PO) 24h and 12h before the trabectedin
iv infusion, 20 mg, iv 30 minutes before the trabectedin infusion, and 4 mg PO 24h, 36h,
48h, 60h, 72h, after the start of trabectedin infusion.


Inclusion Criteria:



- Patient's written informed consent before any clinical trial-specific procedure

- Diagnosis of progressive metastatic breast cancer

- Measurable disease (Patients with bone metastases currently receiving biphosphonates
for palliation will be eligible if other sites of measurable disease are present)

- Adequately recovered from the acute toxicity of any prior treatment

Exclusion Criteria:

- Prior exposure to trabectedin

- More than three prior chemotherapy regimens for metastatic disease

- Pregnant or lactating women or any women of childbearing potential who is not
employing adequate contraception

- Less than 4 weeks from radiation therapy or last dose of hormonal therapy, biological
therapy, therapy with any investigational agent, or chemotherapy (6 weeks if a
nitrosurea or mitomycin C)

- Known clinically relevant CNS metastases. Other serious illnesses such as congestive
heart failure or angina pectoris, myocardial infarction within 1 year before
enrollment, uncontrolled arterial hypertension or arrhythmias.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate with trabectedin in patients with the following metastatic breast cancer subtypes:Group A: triple negative profile (ER-, PR-, HER-2-) Group B: human epidermal growth factor receptor-2 overexpressing tumors (HER-+)

Outcome Time Frame:

Up to approximately 24 months

Safety Issue:

No

Principal Investigator

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Authority:

United States: Food and Drug Administration

Study ID:

CR014764

NCT ID:

NCT00580112

Start Date:

June 2007

Completion Date:

July 2011

Related Keywords:

  • Breast Tumors
  • Breast Tumor
  • Metastatic Breast Cancer
  • triple negative profile
  • HER2 overexpressing tumors
  • BRAC1/2 mutation carriers
  • Triple negative profile
  • Neoplasm Metastasis
  • Breast Neoplasms

Name

Location

New Britain, Connecticut  06052
Alexandria, Minnesota  56308
Phoenix, Arizona  85012
Columbia, Missouri  65203
Albany, New York  12208
Austin, Texas  78705
Seattle, Washington  98195
McLean, Virginia  22101
Denver, Colorado  
Baltimore, Maryland  21287
Indianapolis, Indiana