Trial of Chemotherapy and Avastin as Treatment for Women With Breast Cancer at High Risk for Relapse

NCT00462865 | Terminated Phase 2 Results DMC

• 2 other identifiers: BrUOG BR-213AVF4173s
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 3

Brief Summary

Women with breast cancer who are not eligible for breast conserving surgery or who have node-involvement are sometimes treated with chemotherapy up front, in hopes of allowing for a woman to keep her breast and decreasing the size of the excision for her breast cancer. While current research has shown that survival is the same whether women are treated with chemotherapy first or surgery first for breast cancer, the investigators do not yet know how to treat women with persistent breast cancer after she has received primary chemotherapy. This study looks at the use of a combination regimen of two agents (gemcitabine and capecitabine), both of which are active in breast cancer, and using Avastin to see if this regimen can be given to women treated with primary chemotherapy and then surgery, considered to be at high risk of relapse.

Conditions

Breast Cancer

Keywords

breast cancer; neoadjuvant chemotherapy; adjuvant treatment; consolidation therapy; anti-angiogenesis therapy

Outcome Measures

Primary Outcomes (1)

• Toxicity Related to Treatment

  6 out of 17 patients came off study for toxicity prior to receiving all treatment. Toxicity issues of administering 6 cycles of gemcitabine, capecitabine, and Avastin and one year of consolidation of Avastin in women with breast cancer previously treated with neoadjuvant chemotherapy that lead to patients being taken off study.

  1 year

Secondary Outcomes (1)

• Number of Participants With Recurrent Disease

  6 months and again at the end of the study (1 year)

Study Arms (1)

Gemcitabine and Capecitabine and Avastin

EXPERIMENTAL

Avastin administered concurrently with chemotherapy (Gemcitabine + Capecitabine) for six cycles followed by single agent Avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.

Drug: Gemcitabine and Capecitabine and Avastin

Interventions

Gemcitabine and Capecitabine and Avastin DRUG

avastin administered concurrently with chemotherapy (gemcitabine + capecitabine) for six cycles followed by single agent avastin to complete one year of treatment. Radiation therapy (if planned) will take place after adjuvant chemotherapy completes.

Also known as: Gemzar, Xeloda, Bevacizumab

Gemcitabine and Capecitabine and Avastin

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• General health
• Women Age \>18.
• ECOG Performance status 0-1
• Life expectancy must be 3 months. Clinical stage
• Histologically or cytologically adenocarcinoma of breast
• Pre-operative stage II-III per AJCC 6th edition, based on baseline evaluation by clinical examination, breast imaging, and/or preoperative work-up.
• Evidence of residual invasive breast cancer or node positive disease following neoadjuvant chemotherapy.
• Prior Therapy
• Patients must have received primary (neoadjuvant) chemotherapy for local or locoregional breast cancer containing an anthracycline and a taxane.
• Patients must have completed definitive resection of primary tumor with adequate excision of gross disease.
• Patients must have residual invasive carcinoma in the breast and/or residual carcinoma in one or more regional nodes following preoperative chemotherapy.
• Adequate hematologic and metabolic parameters within four weeks of study entry defined as:
• Absolute neutrophil count ≥1,500/mm3 Platelets ≥ 150,000/mm3
• Total bilirubin ≤ 2.0 mg/dL
• Serum creatinine ≤ 2x upper limit of normal

You may not qualify if:

• Prior therapy
• No prior gemcitabine, continuous infusion 5-FU, or oral fluoropyrimidine (capecitabine, UFT, S-1, 5-FU/eniluracil, etc.)
• No known hypersensitivity to capecitabine or prior unanticipated severe reaction to (capecitabine, UFT, S-1, 5-FU/eniluracil, etc.) therapy or known hypersensitivity to 5-fluorouracil.
• No concurrent or prior endocrine therapy as adjuvant treatment.
• No prior breast radiation
• Current, recent (within 4 weeks of the first infusion of this study), or planned participation in another experimental drug study
• Stage IV breast cancer
• Patients must not have evidence of metastatic disease at enrollment. Women of child-bearing potential.
• Nonpregnant and nonlactating.
• Women of child-bearing potential must have a negative serum pregnancy test and must agree to an effective means of contraception during the entire study period.
• Concurrent medical conditions:
• No other active cancers, except non-melanoma skin cancers.
• No serious infection or other serious underlying medical condition that would otherwise impair their ability to receive protocol treatment.
• Patients with clinically significant medical or psychiatric problems which may interfere with treatment on study.
• Inadequately controlled hypertension (defined as systolic blood pressure 150 and/or diastolic blood pressure \> 100 mmHg on antihypertensive medications)

Sponsors & Collaborators

• Brown University: lead
• Women and Infants Hospital of Rhode Island: collaborator
• Rhode Island Hospital: collaborator
• The Miriam Hospital: collaborator
• Memorial Hospital of Rhode Island: collaborator
• University of New Mexico Cancer Center: collaborator

Study Sites (3)

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87106, United States

Location

Lifespan Hospitals

Providence, Rhode Island, 02903, United States

Location

Women & Infants' Hospital

Providence, Rhode Island, 02905, United States

Location

Related Publications (1)

• Sikov WM, Theall KP, Seidler CW, Strenger RS, Fenton MA. Gemcitabine and capecitabine in metastatic breast cancer (MBC): A Brown University Oncology Group (BrUOG) Proc ASCO; 2005; Orlando, FL; 2005. p. 785.

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Capecitabine; Bevacizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bachir Sakr, MD
• Organization: BrUOG

kayla_rosati@brown.edu

4018633000

Study Officials

• Bachir Sakr, MD

  Women & Infants' Hospital of Rhode Island

  PRINCIPAL INVESTIGATOR

• William Sikov, MD

  Lifespan Hospitals

  PRINCIPAL INVESTIGATOR

• Melanie Royce, MD

  University of New Mexico Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2012
• Study Completion: January 1, 2014
• Last Updated: April 9, 2019
• Results First Posted: April 8, 2015

Record last verified: 2019-04

Locations

US (3)