Phase II Breast Cancer Treatment Using Weekly Carboplatin+Nab-Paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) - Full Text View

Sponsored by:	University of California, Irvine
Information provided by:	University of California, Irvine
ClinicalTrials.gov Identifier:	NCT00618657

Purpose

This study is designed to see if similar chemotherapy prior to surgery can reduce the amount of remaining cancer (shrinking the tumor) thereby allowing surgery as a treatment option and also possibly increase the likelihood of breast conservation (taking less breast tissue) during the surgery. Subjects who agree to participate in this study will receive weekly chemotherapy treatment which will include carboplatin and nab-paclitaxel (Abraxane®), with addition of trastuzumab (Herceptin®, if found to have HER2 positive cancer) or bevacizumab (Avastin®, if they have HER2 negative cancer). Approximately 21-40 days after receiving the chemotherapy subjects will have surgery. Subjects will then be followed for up to 5 years.

Condition	Intervention	Phase
Breast Cancer	Drug: Carboplatin Drug: Nab-paclitaxel Drug: Trastuzumab (for HER2+) Drug: Bevacizumab	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Carboplatin Paclitaxel Bevacizumab Trastuzumab Phenylephrine Guaifenesin Naphazoline Naphazoline hydrochloride Oxymetazoline Oxymetazoline hydrochloride Phenylephrine hydrochloride Phenylpropanolamine Phenylpropanolamine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-Paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

Further study details as provided by University of California, Irvine:

Primary Outcome Measures:

estimate 2yr progression-free survival in pts with breast cancer more than 1 cm &/or lymph node positive breast cancer treated with weekly Carboplatin/Nab-Paclitaxel(with trastuzumab in patients with HER2+ disease,& with bevacizumab in HER2-) [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

to measure clinical response rates in patients treated in the neoadjuvant setting [ Time Frame: 10 years ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	February 2008
Estimated Study Completion Date:	April 2018
Estimated Primary Completion Date:	March 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental weekly chemotherapy treatment which will include carboplatin and nab-paclitaxel (Abraxane®), with addition of trastuzumab (Herceptin®	Drug: Carboplatin weekly, AUC 2 Drug: Nab-paclitaxel weekly, 90 mg/m2 Drug: Trastuzumab (for HER2+) weekly, 4mg/kg induction, followed by weekly 2mg/kg Drug: Bevacizumab every other week, 10mg/Kg

Eligibility

Ages Eligible for Study:	21 Years to 90 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Are between 21and 90 years old
Have Stage II or III breast cancer which is not immediately treatable with surgery, or with clinically documented enlarged lymph nodes
Other than having cancer, are in general good health (your doctor will determine this from your lab work and imaging results)

Exclusion Criteria:

Are pregnant
Have congestive heart failure
Are unwilling to give informed consent.
Have implanted prosthetic heart valves, pacemaker, neuro-stimulation devices, surgical clips (hemostatic clips) or other metallic implants
Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities
Have received orthodontic work involving ferromagnetic materials
Are claustrophobic
Have had allergic response to MR contrast agents (gadolinium) previously
Have known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00618657

Contacts

Contact: Chao Family Comprehensive Cancer Center University of California, Irvine Medical Center

877-82-78839

UCstudy@uci.edu

Locations

United States, California
Chao Family Comprehensive Cancer Center	Recruiting
Orange, California, United States, 92868
Contact 877-827-8839 UCstudy@uci.edu
Principal Investigator: Rita Mehta, M.D.

Sponsors and Collaborators

University of California, Irvine

Investigators

Principal Investigator:

Rita Mehta, M.D.

Chao Family Comprehensive Cancer Center

More Information

Responsible Party:	Chao Family Comprehensive Cancer Center ( Rita Mehta, M.D. )
Study ID Numbers:	UCI 07-61, HS#2007-6084
Study First Received:	February 7, 2008
Last Updated:	January 2, 2009
ClinicalTrials.gov Identifier:	NCT00618657
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Irvine:

pre-operative
neo-adjuvant
triple negative
HER2 positive
hormone receptor positive
breast

Carboplatin
Nab-paclitaxel
Trastuzumab
Bevacizumab
Inflammatory

Study placed in the following topic categories:

Naphazoline
Oxymetazoline
Skin Diseases
Guaifenesin
Phenylephrine
Paclitaxel

Trastuzumab
Breast Neoplasms
Carboplatin
Phenylpropanolamine
Bevacizumab
Breast Diseases

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Mitosis Modulators
Antimitotic Agents
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Tubulin Modulators
Growth Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009