First Line Therapy for Patients With Metastatic Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Celgene Corporation
ClinicalTrials.gov Identifier:
NCT00456846
First received: April 3, 2007
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to determine the toxicity and anti-tumor activity of ABI-007 100mg/m^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: ABI-007
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Phase II Study of Weekly ABI-0007 as First Line Therapy for Patients With Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by Celgene Corporation:

Primary Outcome Measures:
  • to determine the toxicity and anti tumor activity of ABI-007 [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
  • Complete or Partial Response [ Designated as safety issue: No ]
    Percentage of patients who achieve an objective confirmed or partial overall response based on the RECIST response criteria


Secondary Outcome Measures:
  • Disease Control [ Designated as safety issue: No ]
    Percentage of participants with stable disease for > or + 16 weeks, or complete or partial overall response

  • Progression-free survival [ Designated as safety issue: No ]
    Number of participants who survive without disease progression

  • Duration of response [ Designated as safety issue: No ]
    Duration of response

  • Survival [ Designated as safety issue: No ]
    Number of participants alive or dead

  • Adverse events [ Designated as safety issue: Yes ]
    Number of participants with adverse events


Enrollment: 123
Study Start Date: February 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABI-007 Drug: ABI-007
100 mg/m2 ABI-007 will be administered by intravenous infusion over 30 minutes weekly for 3 weeks followed by 1 week rest

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females with pathologically confirmed adenocarcinoma of the breast.
  • No prior chemotherapy for metastatic breast cancer
  • At least 12 months between completion of adjuvant chemotherapy and the diagnosis of metastatic disease
  • Stage IV disease
  • Measurable disease (must be equal or greater to 2.0cm using conventional CT or equal or greater to 1.0 cm using spiral CT except for pulmonary lesions that are well documented on conventional CT scan which must be equal or greater than 1.0 cm)
  • At least 4 weeks since radiotherapy, with full recovery. The measurable disease must be completely outside the radiation portal or there must be radiologic or clinical exam proof of progressive disease within the radiation portal
  • At least 4 weeks since major surgery, with full recovery
  • ECOG performance status 0-2
  • Age equal or greater to 18
  • Patients has the following blood counts at Baseline:
  • ANC equal or greater to 1.5 x 10^9 cells/L
  • Platelets equal or greater to 100 x 10^9 cells/L
  • Hgb equal or greater to 90 grams/L
  • Patients has the following blood chemistry levels at Baseline:
  • AST (SGOT), ALT (SGPT)less than or equal to 2.5x upper limit of normal range (ULN);
  • total bilirubin normal (unless bilirubin elevation is due to Gilbert's (Disease);
  • alkaline phosphatase less than or equal 2.5x ULN (unless bone metastasis is present in the absence of liver metastasis);
  • creatinine less than or equal to 1.5mg/dL
  • Current sensory neuropathy Grade 0 or 1 by BCI CTCAE
  • If female of childbearing potential, pregnancy test is negative (within 72 hours of the first dose of study drug).
  • If fertile, the patient agrees to use an effective method of contraception to avoid pregnancy for the duration of the study
  • Patient is able to supply unstained slides or 1 tumor block of her primary breast tumor or a biopsy of a current site of metastasis for SPARC analysis
  • Informed consent has been obtained

Exclusion Criteria:

  • Concurrent immunotherapy or hormonal therapy (other than Herceptin) for breast cancer
  • Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment
  • Serious intercurrent medical or psychiatric illness, including serious active infection
  • History of class II-IV congestive heart failure
  • History of other malignancy within the last 5 years which could affect the diagnoses or assessment of breast cancer, with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
  • Patients who have received an investigational drug within the previous 3 weeks
  • Patient is currently enrolled in a different clinical study in which investigational procedures are performed or investigational therapies are administered. Also a patient may not enroll in such clinical trials while participating in this study.
  • Pregnant or nursing women
  • Patients with prior hypersensitivity to Taxol or Taxotere
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456846

Locations
Canada, British Columbia
BC Cancer Agency-Burnaby
Burnaby, British Columbia, Canada
Lions Gate Hospital
North Vancouver, British Columbia, Canada
B.C.C.A Vancouver Island Center
Victoria, British Columbia, Canada
Canada, Newfoundland and Labrador
Dr. H. Bliss Murphy Cancer Center
St. Johns, Newfoundland and Labrador, Canada
Canada, Ontario
The Royal Victoria Hospital
Barrie, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Toronto Synnybrook Cancer Centre
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Windsor Regional Hospital
Windsor, Ontario, Canada
Canada, Quebec
Hospital de la Cite-de-la Sante-de-Laval
Laval, Quebec, Canada
McGill University
Montreal, Quebec, Canada
Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu
Montreal, Quebec, Canada
Canada
CHA: Saint Sacrement Hospital
Quebec, Canada
Sponsors and Collaborators
Celgene Corporation
Investigators
Principal Investigator: Sasha Smiljanik, MD Lions Gate Hospital
Principal Investigator: Kara Laing, MD Dr. H. Bliss Murphy Cancer Center
Principal Investigator: Wendy Lam, MD BC Cancer Agency-Burnaby
Principal Investigator: Maureen Trudeau, MD Toronto Sunnybrook Cancer Centre
Principal Investigator: Vanessa Bernstein, MD B.C.C.A. Vancouver Island Center
Principal Investigator: Jawaid Younus, MD London Regional Cancer Centre
Principal Investigator: Lawrence Panasci, MD McGill University
Principal Investigator: Guy Cantin, MD CHA: Saint Sacrement Hospital
Principal Investigator: Nicolas Raymond, MD Hospital de la Cite-de-la Sante-de-Laval
Principal Investigator: Robert El-Maraghi, MD The Royal Victoria Hospital
Principal Investigator: Christine Brezden-Masley, MD St. Michael's Hospital, Toronto
Principal Investigator: Andre Robidoux, MD Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu
Principal Investigator: Martin Blackstein, MD Mount Sinai Hospital, New York
Principal Investigator: Caroline Hamm, MD Windsor Regional Cancer Center
  More Information

No publications provided

Responsible Party: Celgene Corporation
ClinicalTrials.gov Identifier: NCT00456846     History of Changes
Other Study ID Numbers: CA042
Study First Received: April 3, 2007
Last Updated: April 16, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Celgene Corporation:
Metastatic Breast Cancer, ABI-007, Abraxane

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014