First Line Therapy for Patients With Metastatic Breast Cancer

NCT00456846 | Terminated Phase 2 Results

• 1 other identifier: CA042
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 14

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer, ABI-007, Abraxane

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent Reviewers

  Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the baseline sum of the longest diameters confirmed at least 4 weeks after initial documentation. PR is also recorded when all measurable disease has completely disappeared, but a non-measurable component (i.e., ascites) is still present but not progressing. As well as persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits

  Every 8 weeks from study start until disease progression; Up to 61 months

Secondary Outcomes (7)

• Percentage of Participants With Disease Control

  Every 8 weeks from study start until disease progression; Up to 61 months

• Progression-free Survival (PFS)

  Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months

• Duration of Response Based on Independent Reviewer Assessment

  Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months

• Duration of Response Based on Investigator Assessment

  Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months

• Patient Survival

  Study start until death, or until data cut-off 31 May 2013; up to 61 months

Study Arms (1)

ABI-007

EXPERIMENTAL

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.

Drug: ABI-007

Interventions

ABI-007 DRUG

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

Also known as: Nab-paclitaxel, Abraxane

ABI-007

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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);

You may not qualify if:

• 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

Sponsors & Collaborators

• Celgene: lead

Study Sites (14)

BC Cancer Agency-Burnaby

Burnaby, British Columbia, Canada

Location

Lions Gate Hospital

North Vancouver, British Columbia, Canada

Location

B.C.C.A Vancouver Island Center

Victoria, British Columbia, Canada

Location

Dr. H. Bliss Murphy Cancer Center

St. John's, Newfoundland and Labrador, Canada

Location

The Royal Victoria Hospital

Barrie, Ontario, Canada

Location

London Regional Cancer Centre

London, Ontario, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

St. Michael's Hospital

Toronto, Ontario, Canada

Location

Toronto Synnybrook Cancer Centre

Toronto, Ontario, Canada

Location

Windsor Regional Hospital

Windsor, Ontario, Canada

Location

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

Laval, Quebec, Canada

Location

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

Montreal, Quebec, Canada

Location

McGill University

Montreal, Quebec, Canada

Location

CHA: Saint Sacrement Hospital

Québec, Canada

Location

Related Publications (1)

• 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.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Anne McClain
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

888-260-1599

Study Officials

• 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

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

• Andre Robidoux, MD

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

  PRINCIPAL INVESTIGATOR

• Martin Blackstein, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Caroline Hamm, MD

  Windsor Regional Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2007
• First Posted: April 5, 2007
• Study Start: February 1, 2008
• Primary Completion: December 11, 2012
• Study Completion: May 31, 2013
• Last Updated: November 22, 2019
• Results First Posted: July 18, 2014

Record last verified: 2019-11

Locations

CA (14)