Clinical trial NCT00456846: First Line Therapy for Patients With Metastatic Breast Cancer
Official title: An Open-Label, Phase II Study of Weekly ABI-007 as First Line Therapy for Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Keywords: Metastatic Breast Cancer, ABI-007, Abraxane
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: Every 8 weeks from study start until disease progression; Up to 61 months
Secondary outcomes:
measure: Percentage of Participants With Disease Control
timeFrame: Every 8 weeks from study start until disease progression; Up to 61 months
measure: Progression-free Survival (PFS)
timeFrame: Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months
measure: Duration of Response Based on Independent Reviewer Assessment
timeFrame: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
measure: Duration of Response Based on Investigator Assessment
timeFrame: Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
measure: Patient Survival
timeFrame: Study start until death, or until data cut-off 31 May 2013; up to 61 months
measure: Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study Drug
timeFrame: Day 1 of study drug to Day 940; data cut off 31 May 2013
measure: Number of Participants With Treatment-Emergent Adverse Events
timeFrame: Day 1 to Day 940
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: BC Cancer Agency-Burnaby
state: British Columbia
city: North Vancouver
country: Canada
facility: Lions Gate Hospital
state: British Columbia
city: Victoria
country: Canada
facility: B.C.C.A Vancouver Island Center
state: British Columbia
city: St. Johns
country: Canada
facility: Dr. H. Bliss Murphy Cancer Center
state: Newfoundland and Labrador
city: Barrie
country: Canada
facility: The Royal Victoria Hospital
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Toronto Synnybrook Cancer Centre
state: Ontario
city: Windsor
country: Canada
facility: Windsor Regional Hospital
state: Ontario
city: Laval
country: Canada
facility: Hospital de la Cite-de-la Sante-de-Laval
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu
state: Quebec
city: Montreal
country: Canada
facility: McGill University
state: Quebec
city: Quebec
country: Canada
facility: CHA: Saint Sacrement Hospital
Study officials:
affiliation: Lions Gate Hospital
name: Sasha Smiljanik, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr. H. Bliss Murphy Cancer Center
name: Kara Laing, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: BC Cancer Agency-Burnaby
name: Wendy Lam, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Sunnybrook Cancer Centre
name: Maureen Trudeau, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: B.C.C.A. Vancouver Island Center
name: Vanessa Bernstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: London Regional Cancer Centre
name: Jawaid Younus, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Lawrence Panasci, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHA: Saint Sacrement Hospital
name: Guy Cantin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de la Cite-de-la Sante-de-Laval
name: Nicolas Raymond, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Royal Victoria Hospital
name: Robert El-Maraghi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Unity Health Toronto
name: Christine Brezden-Masley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre Hospitalier de l'Universite de Montreal-Hotel-Dieu
name: Andre Robidoux, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MOUNT SINAI HOSPITAL
name: Martin Blackstein, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Windsor Regional Cancer Center
name: Caroline Hamm, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.