Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients

NCT00428922 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: OSU-06027NCI-2011-03219
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.

Conditions

Breast Cancer

Keywords

Metastatic; Breast Cancer; MBC

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) and to Evaluate Safety of the Trastuzumab, Bevacizumab and Docetaxel Regimen.

  The trial was designed as a single-stage phase II rather then usual two-stage design because of the progression free survival (PFS) primary endpoint, as it is impractical to wait to assess PFS for patients in the first stage. We will consider a PFS of 50% at twelve months (median PFS of 12 months) or less uninteresting and a PFS of 70% at twelve months (median PFS of twenty months) worthy of pursuing the regimen in a future trials. The single-stage design is as follows: p0=0.50, p1=0.70, α=0.10, β= 0.10. This leads to a total sample size of 39 patients, 24 or higher of who are progression-free at 12 months.

  up to 3 years

Secondary Outcomes (3)

• Changes in CTCs as Predictors of PFS and Clinical Benefit

  Day 1 and Day 22

• Overall Clinical Benefit Rate (CR+PR+SD)

  at least 24 weeks

• Changes in CECs as Predictors of PFS and Clinical Benefit

  Day 1 and Day 22

Study Arms (1)

Trastuzumab, Bevacizumab, and Docetaxel

EXPERIMENTAL

Trastuzumab \[6mg/kg\], Bevacizumab \[15mg/kg\], and Docetaxel \[75 mg/M²\]

Drug: Trastuzumab; Drug: Bevacizumab; Drug: Docetaxel

Interventions

Trastuzumab DRUG

administered every three weeks on day 1, every 21 days. The dose given will be 6 mg/kg. The initial loading dose is 8mg/kg and is administered as a 90-minute infusion. Thereafter, the maintenance dose is 6mg/kg every three weeks administered as a 30 minute infusion (unless the treating physician indicates a longer infusion duration is warranted). Trastuzumab is given prior to bevacizumab. Trastuzumab is to be continued until disease progression or unacceptable toxicity.

Also known as: Herceptin

Trastuzumab, Bevacizumab, and Docetaxel

Bevacizumab DRUG

administered every three weeks on day 1, every 21 days. The dose given will be 15 mg/kg. The initial dose is administered over 90 minutes. If the first infusion is well tolerated, the second dose is given over 60 minutes, and if that is well tolerated, then subsequent doses may be given over 30 minutes. Avastin is given after trastuzumab and prior to docetaxel.

Also known as: Avastin

Trastuzumab, Bevacizumab, and Docetaxel

Docetaxel DRUG

administered every three weeks on day 1, every 21 days. The dose given will be 75 mg/M². All doses of docetaxel are administered over 60 minutes. Docetaxel is given after trastuzumab and bevacizumab.

Also known as: Taxotere

Trastuzumab, Bevacizumab, and Docetaxel

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed breast cancer with evidence of metastatic disease
• HER2 3+ or FISH (fluorescent in situ hybridization)+
• Age ≥ 18 years
• No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.
• No prior chemotherapy in the metastatic setting.

You may not qualify if:

• CNS (central nervous system) metastases
• Prior radiation therapy within the last 4 weeks
• Pregnant (positive pregnancy test) or lactating women
• Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study
• Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to start of study.

Sponsors & Collaborators

• Bhuvaneswari Ramaswamy: lead
• Genentech, Inc.: collaborator
• Case Comprehensive Cancer Center: collaborator
• University of Pittsburgh: collaborator

Study Sites (3)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

• Puhalla S, Mrozek E, Young D, Ottman S, McVey A, Kendra K, Merriman NJ, Knapp M, Patel T, Thompson ME, Maher JF, Moore TD, Shapiro CL. Randomized phase II adjuvant trial of dose-dense docetaxel before or after doxorubicin plus cyclophosphamide in axillary node-positive breast cancer. J Clin Oncol. 2008 Apr 1;26(10):1691-7. doi: 10.1200/JCO.2007.14.3941. Epub 2008 Mar 3.

  PMID: 18316792 RESULT

Related Links

• Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Trastuzumab; Bevacizumab; Docetaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Bhuvaneswari Ramaswamy, MD
• Organization: The Ohio State University Comprehensive Cancer Center

Bhuvaneswari.Ramaswamy@osumc.edu

614-293-0066

Study Officials

• Bhuvaneswari Ramaswamy, MD

  Ohio State University

  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 INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 29, 2007
• First Posted: January 30, 2007
• Study Start: June 14, 2007
• Primary Completion: November 1, 2012
• Study Completion: February 7, 2017
• Last Updated: August 9, 2018
• Results First Posted: February 12, 2016

Record last verified: 2018-07

Locations

US (3)