Prediction of Response to Neoadjuvant Chemotherapy in Women With Operable Breast Cancer
PT-304
1 other identifier
observational
134
1 country
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 3, 2009
CompletedFirst Posted
Study publicly available on registry
November 5, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedOctober 5, 2012
October 1, 2012
2.9 years
November 3, 2009
October 4, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary clinical endpoint pCR will be a dichotomous outcome variable with two levels: complete response and no complete response.
24 months
Secondary Outcomes (1)
Secondary clinical endpoint cOR will be an ordinal outcome variable with complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) four levels.
24 months
Interventions
Test of an algorithm to predict pathologic response in patients treated with neoadjuvant chemotherapy for breast cancer.
Eligibility Criteria
Women 18 years or older with Palpable Operable Breast Cancer Measurable Disease
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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Precision Therapeuticslead
- United States Department of Defensecollaborator
Study Sites (28)
Breastlink Medical Group, Inc
Long Beach, California, 90806, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Advanced Breast Care
Marietta, Georgia, 30060, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89074, United States
Breast Care
Las Vegas, Nevada, 89106, United States
Morristown Memorial Hospital
Morristown, New Jersey, 07962, United States
Beth Israel Medical Center
New York, New York, 10003, United States
OU Medical Center
Oklahoma City, Oklahoma, 73104, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477, United States
Breast Care Specialists, P.C.
Allentown, Pennsylvania, 18104, United States
Magee Womens Hospital
Pittsburgh, Pennsylvania, 15213, United States
Women & Infants Hospital
Providence, Rhode Island, 02905, United States
Breast Clinic of Memphis
Germantown, Tennessee, 38138, United States
Advantage Clinical Research
Nashville, Tennessee, 37203, United States
Tennessee Breast Specialists
Nashville, Tennessee, 37203, United States
Texas Oncology - Bedford
Bedford, Texas, 76022, United States
Dallas Surgical Group
Dallas, Texas, 75230, United States
Leading Edge Research, PA
Dallas, Texas, 75230, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, 75231, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology - Memorial City
Houston, Texas, 77024, United States
Cancer Care Centers of South Texas
San Antonio, Texas, 78217, United States
Southlake Oncology
Southlake, Texas, 76092, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Aurora Sinai Medical Center
Milwaukee, Wisconsin, 53233, United States
Biospecimen
Core needle biopsy specimens will be collected and stored in RNAlater® until the time of RNA extraction, using standard procedures. Isolated total RNA will be assayed for gene expression using methods such as TaqMan® RT-PCR technology or Affymetrix or Agilent gene array platforms.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Darrell Lis, RN, MSN
Precision Therapeutics
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2009
First Posted
November 5, 2009
Study Start
November 1, 2009
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
October 5, 2012
Record last verified: 2012-10