First Line Therapy for Patients With Metastatic Breast Cancer

NCT ID: NCT00456846

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 123 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-01
• Study Completion Date: 2013-05-31

Brief Summary

The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 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.

Detailed Description

This is an open-label, phase II study to determine the toxicity and antitumor activity of ABI-007 100 mg/m2 administered weekly for 3 weeks followed by a rest week (4-week cycle) as first line therapy to patients with metastatic breast cancer in the following 2 cohorts: Patients who have received a taxane as part of their adjuvant therapy, and patients who did not receive a taxane as part of their adjuvant therapy. Patients will be assessed for antitumor response every 8 weeks.

The last subject received study treatment 11DEC2012. The study was terminated on 31 May 2013 via a notification letter to all investigators on 14 May 2013.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ABI-007

100 mg/m\^2 ABI-007 was administered by intravenous (IV) infusion over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

ABI-007

Intervention Type: DRUG

100 mg/m\^2 ABI-007 weekly for 3 weeks followed by 1 week rest

Interventions

ABI-007

100 mg/m\^2 ABI-007 weekly for 3 weeks followed by 1 week rest

Intervention Type: DRUG

Other Intervention Names

Nab-paclitaxel; Abraxane

Eligibility 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 2.0 cm using conventional Computed Tomography (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
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Age equal or greater to 18
• Patients has the following blood counts at Baseline:
• Absolute Neutrophil Count (ANC) equal or greater to 1.5 x 10^9 cells/L
• Platelets equal or greater to 100 x 10^9 cells/L
• Hemoglobin (Hgb) equal or greater to 90 grams/L
• Patients has the following blood chemistry levels at Baseline:
• Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT), alanine aminotransferase (ALT) serum glutamic:pyruvic transaminase (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 Breast Cancer Index (BCI) Common Toxicity Criteria Adverse Events (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 Secreted protein acidic and rich in cysteine (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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celgene

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sasha Smiljanik, MD

Role: PRINCIPAL_INVESTIGATOR

Lions Gate Hospital

Kara Laing, MD

Role: PRINCIPAL_INVESTIGATOR

Dr. H. Bliss Murphy Cancer Center

Wendy Lam, MD

Role: PRINCIPAL_INVESTIGATOR

BC Cancer Agency-Burnaby

Maureen Trudeau, MD

Role: PRINCIPAL_INVESTIGATOR

Toronto Sunnybrook Cancer Centre

Vanessa Bernstein, MD

Role: PRINCIPAL_INVESTIGATOR

B.C.C.A. Vancouver Island Center

Jawaid Younus, MD

Role: PRINCIPAL_INVESTIGATOR

London Regional Cancer Centre

Lawrence Panasci, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Guy Cantin, MD

Role: PRINCIPAL_INVESTIGATOR

CHA: Saint Sacrement Hospital

Nicolas Raymond, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de la Cite-de-la Sante-de-Laval

Robert El-Maraghi, MD

Role: PRINCIPAL_INVESTIGATOR

The Royal Victoria Hospital

Christine Brezden-Masley, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Andre Robidoux, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu

Martin Blackstein, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Caroline Hamm, MD

Role: PRINCIPAL_INVESTIGATOR

Windsor Regional Cancer Center

Locations

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

Dr. H. Bliss Murphy Cancer Center

St. John's, Newfoundland and Labrador, Canada

The Royal Victoria Hospital

Barrie, Ontario, Canada

London Regional Cancer Centre

London, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

St. Michael's Hospital

Toronto, Ontario, Canada

Toronto Synnybrook Cancer Centre

Toronto, Ontario, Canada

Windsor Regional Hospital

Windsor, Ontario, Canada

Hospital de la Cite-de-la Sante-de-Laval

Laval, Quebec, Canada

Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu

Montreal, Quebec, Canada

McGill University

Montreal, Quebec, Canada

CHA: Saint Sacrement Hospital

Québec, , Canada

Countries

Canada

References

Brezden B, et al. An open-label, phase II study of weekly nab-paclitaxel as first-line therapy for patients (pts) with metastatic breast cancer (MBC): Safety update. Presented at 2010 ASCO Annual Meeting, June 4-8, 2010, Chicago, IL. Abstract No 1127 C.

Reference Type: BACKGROUND

Other Identifiers

CA042

Identifier Type: -

Identifier Source: org_study_id