Abraxane, Avastin, and Gemcitabine as First-Line Therapy for Patients With Metastatic Breast Cancer

NCT00503906 | Completed Phase 2 Results DMC

• 2 other identifiers: 20060913SCCC-2006081
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators hypothesize that the combination of Gemzar®, Abraxane® and Avastin will increase the progression-free survival (PFS) in patients with first line metastatic breast cancer and in patients who received neoadjuvant and/or adjuvant chemotherapy present with definable metastatic disease, 6 or more months after primary treatment.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; recurrent breast cancer

Outcome Measures

Primary Outcomes (1)

• Median Progression-Free Survival

  Progression-free survival will be measured from the first dose date to the earliest date of documented evidence of progressive disease or the date of death due to any causes, whichever occurs first.

  Up to 24 months

Secondary Outcomes (4)

• Rates of Partial Response (PR), Complete Response (CR) and Overall Response (ORR) in Study Participants

  After two cycles, about 60 days

• Rate of Toxicity in Study Participants

  Over the course of study treatment.

• Relationship Between Circulating Tumor Cells (CTC) and Disease Progression as Measured by Presence of CTC at Baseline and Over the Course of Study Treatment

  Baseline, over the course of Treatment, about 1 year

• Relationship Between SPARC Expression and Response to Protocol Therapy.

  Baseline, over the course of treatment, about 1 year

Study Arms (1)

Abraxane, Avastin and Gemcitabine

EXPERIMENTAL

Each treatment cycle is 28 days. Participants will be treated until disease progression: * Gemcitabine: 1500 mg/m2 body surface area (BSA) intravenously (IV) over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Abraxane: 150 mg/m2 IV over 30 minutes (+/- 5 minutes) on days 1 and 15 of each cycle, followed by; * Avastin: 10 mg/kg IV on days 1 and 15 of each cycle.

Drug: Avastin; Drug: Gemcitabine; Drug: Abraxane

Interventions

Avastin DRUG

Also known as: Bevacizumab

Abraxane, Avastin and Gemcitabine

Gemcitabine DRUG

Also known as: Gemzar

Abraxane, Avastin and Gemcitabine

Abraxane DRUG

Also known as: Albumin-Bound Paclitaxel Formulation

Abraxane, Avastin and Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must either be:
• treatment-naïve with newly diagnosed her2neu non-overexpressing (non amplified) metastatic (Stage IV) breast cancer, or
• HER2/neu-negative patients with metastasis diagnosed 6 or more months after completing primary systemic treatment (neoadjuvant, adjuvant chemotherapy).
• No previous chemotherapy regimen for metastatic breast cancer.
• years of age or older.
• Measurable disease as defined by RECIST criteria or evaluable disease.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Life expectancy greater than 3 months.
• For female (or male) patients, either pre- or post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control for the duration of the study
• Provide written informed consent before any study-related procedure not part of normal medical care is conducted
• Willing and able to comply with the protocol requirement
• Laboratory parameters as follows:
• Neutrophils: 1.5 x109/L or greater
• Platelets: 100 x109/L or greater
• Hemoglobin: ≥ 9.0 g/dL

You may not qualify if:

• Previous treatment with gemcitabine.
• History of Gastrointestinal Bleeding in the previous 3 months.
• Chemotherapy within 4 weeks prior to enrollment.
• Radiation therapy or evidence of acute effects of radiation therapy within 2 weeks prior to enrollment.
• Any major surgery within 4 weeks prior to enrollment.
• Presence of central nervous system or brain metastases.
• Urine protein: creatinine ratio ≥ 1.0 at screening.
• Inadequately controlled hypertension (defined as systolic blood pressure \> 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications).
• A prior history of hypertensive crisis or hypertensive encephalopathy.
• Peripheral neuropathy \> grade I.
• Clinical AIDS or known positive HIV serology
• No concurrent clinically evident malignancy is allowed except inactive non-melanoma skin cancer and inactive cervical cancer diagnosed or other cancer for which the patient has been disease-free for five years.
• Unstable angina.
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction within 6 months.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

Related Publications (1)

• Lobo C, Lopes G, Baez O, Castrellon A, Ferrell A, Higgins C, Hurley E, Hurley J, Reis I, Richman S, Seo P, Silva O, Slingerland J, Tukia K, Welsh C, Gluck S. Final results of a phase II study of nab-paclitaxel, bevacizumab, and gemcitabine as first-line therapy for patients with HER2-negative metastatic breast cancer. Breast Cancer Res Treat. 2010 Sep;123(2):427-35. doi: 10.1007/s10549-010-1002-0. Epub 2010 Jun 29.

  PMID: 20585851 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Bevacizumab; Gemcitabine; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins

Results Point of Contact

• Title: Stefan Gluck MD
• Organization: UM/Sylvester Comprehensive Cancer CEnter

sgluck@med.miami.edu

305-243-4909

Study Officials

• Stefan Glück, MD, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: July 17, 2007
• First Posted: July 19, 2007
• Study Start: June 1, 2007
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 12, 2017
• Results First Posted: April 2, 2013

Record last verified: 2017-05

Locations

US (1)