Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer

Stopped early

Conditions studied: Breast Cancer

In brief

The objective of this study is to develop a biomarker to predict pathological complete response in women treated with neoadjuvant chemotherapy for breast cancer. Such a biomarker would assist physicians in selecting the most effective chemotherapy for the individual patient.

Key facts

Study ID

NCT01007890

Run by

Precision Therapeutics

People needed

134

Starts

2009-11-01

Expected to finish

2012-10-01

Last updated by the study team

2012-10-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female subjects who satisfy the following conditions will be considered for enrollment into the study:
• The subject must consent to be in the research study and must have signed an approved consent form conforming to institutional guidelines prior to study entry.
• The diagnosis of breast cancer can be made by FNA or biopsy (other than incisional or excisional). The tumor specimen must demonstrate a diagnosis of invasive adenocarcinoma.
• The primary breast cancer must be operable and measurable "greater than or equal to" 2.0 cm by use of physical exam and/or ultrasound, MRI, CT scan, or mammogram.
• T1c, T2, T3, or T4 patients clinically staged as M0 (non-inflammatory) are eligible.
• Patients with a prior diagnosis and treatment for DCIS are eligible.
• Patients with multi-focal breast cancer are eligible.
• The tumor must be confined to either the breast or to the breast and ipsilateral axilla.
• The subject must be 18 years or older.
• The interval between initial cytologic or histologic diagnosis of breast cancer and registration must be no more than 10 weeks.
• ECOG Performance Status of 0 or 1 (see Appendix A) is required.
• The subject must receive standard of care chemotherapy regimens consisting of either doxorubicin (A), cyclophosphamide (C), and a taxane (T) such as docetaxel, paclitaxel, or nab-paclitaxel administered in any sequence and combination the treating physician determines or docetaxel (T) plus cyclophosphamide (C).

You may not qualify if…

• Male subjects are not eligible for this study as the incidence of breast cancer in male subjects is significantly lower than female subjects. Those subjects who are strongly HER2-positive will be excluded as they will require treatment by biological agents for which the ChemoResponse Assay has not yet been validated. Subjects with evidence of distant metastatic disease are excluded as these subjects would not be good candidates for neoadjuvant therapy. Women who have had an excisional or incisional biopsy prior to entry would not have sufficient tumor sample to test or to be measured by physical exam for the study. Women who have nonmalignant comorbid conditions and diseases that would preclude them from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study are also excluded. Women with psychiatric or addictive disorders are excluded to protect those vulnerable subjects who may not be able to adequately give informed consent.
• Women with one or more of the following conditions will be ineligible for this study:
• Tumor determined to be strongly HER2-positive by immunohistochemistry (3+) or by fluorescent in situ hybridization (positive for gene amplification)
• Definitive clinical or radiologic evidence of distant metastatic disease.
• Excisional or incisional biopsy for this primary breast tumor.
• Inflammatory breast cancer.
• Synchronous contra-lateral breast cancer.
• Multi-centric breast cancer.
• Participation in the NSABP B-40 study.
• Prior therapy for invasive breast cancer, including irradiation, chemo-, immuno-, and/or hormonal therapy.
• a. Note: the only exception is hormonal therapy, which may have been given anytime after diagnosis and before study entry as long as the hormonal therapy is discontinued at or before registration. After surgery, hormonal therapy may be re-started, at the discretion of the treating physician.
• Current therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention, or sex hormonal therapy such as birth control pills, ovarian hormonal replacement therapy, etc. These patients are eligible IF these medications are discontinued prior to registration.
• Surgical axillary staging procedure prior to study entry.
• a. Note: exceptions include FNA of an axillary node and pre-neoadjuvant sentinel lymph node biopsy for patients with clinically negative axillary nodes.
• Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the woman from being treated with doxorubicin (A), cyclophosphamide (C), and a taxane (T), and from completing the study.
• Psychiatric or addictive disorders that would preclude obtaining informed consent.

Where it is running

• Breastlink Medical Group, Inc — Long Beach, California, United States
• USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Advanced Medical Specialties — Miami, Florida, United States
• Advanced Breast Care — Marietta, Georgia, United States
• Missouri Cancer Associates — Columbia, Missouri, United States
• Comprehensive Cancer Centers of Nevada — Henderson, Nevada, United States
• Breast Care — Las Vegas, Nevada, United States
• Morristown Memorial Hospital — Morristown, New Jersey, United States
• Beth Israel Medical Center — New York, New York, United States
• OU Medical Center — Oklahoma City, Oklahoma, United States
• Willamette Valley Cancer Institute and Research Center — Springfield, Oregon, United States
• Breast Care Specialists, P.C. — Allentown, Pennsylvania, United States
• Magee Womens Hospital — Pittsburgh, Pennsylvania, United States
• Women & Infants Hospital — Providence, Rhode Island, United States
• Breast Clinic of Memphis — Germantown, Tennessee, United States
• Advantage Clinical Research — Nashville, Tennessee, United States
• Tennessee Breast Specialists — Nashville, Tennessee, United States
• Texas Oncology - Bedford — Bedford, Texas, United States
• Dallas Surgical Group — Dallas, Texas, United States
• Leading Edge Research, PA — Dallas, Texas, United States
• Texas Oncology - Dallas Presbyterian Hospital — Dallas, Texas, United States
• Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• Texas Oncology - Memorial City — Houston, Texas, United States
• Cancer Care Centers of South Texas — San Antonio, Texas, United States
• Southlake Oncology — Southlake, Texas, United States

Full record on ClinicalTrials.gov

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