Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients
This study is currently recruiting participants.
Verified January 2013 by Roswell Park Cancer Institute
Sponsor:
Roswell Park Cancer Institute
Collaborators:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01027416
First received: December 4, 2009
Last updated: January 15, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will help to understand the interaction between the hormonal therapy Tamoxifen, estrogen receptors and certain genes in the cancer cell. This information may eventually help select the appropriate therapy for future patients with similar cancer.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Drug: Tamoxifen |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pilot Study to Analyze a Novel Mechanism Underlying Response to Tamoxifen Therapy in Breast Cancer Patients |
Resource links provided by NLM:
Further study details as provided by Roswell Park Cancer Institute:
Primary Outcome Measures:
- Investigate the status of ERά-p53 interaction in ERά-positive, p53-wild type breast tumors in untreated patients and examine how tamoxifen therapy modifies this reaction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Confirm the wild type status of p53 and analyze the functional status of p53 pathway by monitoring expression of selected p53-target genes in tumors in patients who have or have not been treated with tamoxifen [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | December 2009 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: No Intervention | |
|
Active Comparator: Tamoxifen
Tamoxifen 20 mg orally 1x/day for 4 weeks
|
Drug: Tamoxifen
Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks
|
Detailed Description:
Women with abnormal mammogram or suspicious masses will undergo diagnostic core biopsies which will be analyzed for ER/PR and HER2Neu expression. For patients that are ER positive, P53 staining will be done.
Women presenting tumors with an Allred score of 3 or greater status will be approached to participate.
Women will be randomized to either standard of care surgical therapy or a 4 week intervention of Tamoxifen 20mg daily for 4 weeks prior to surgery. During the intervention, blood draws will be done to measure levels of tamoxifen metabolites in the blood and test for polymorphisms that may decrease levels of active metabolites.
Women will undergo two blood draws for PK/PD and one for pharmacogenomics.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The patient must consent to be in the study and must have signed an approved consent form conforming to institutional guidelines
- The patient must be 18 years or older
- Core biopsy should definitively demonstrate invasive carcinoma
- Invasive carcinoma should be ERά receptor positive
- The tumor should be approximately 1 cm, but at least 5mm to account for variability in imaging and imaging occult disease(physical exam, mammography, ultrasound).
- Patients in whom surgical excision of the tumor is part of standard of care management
- ECOG of 0 or 1
- Negative serum or urine β-hCG pregnancy test at screening for patients of child-bearing potential(this is routinely done if premenopausal and having surgery)
- Consent to participate in DBBR
Exclusion Criteria:
- Male patients are not eligible for this study
- Female patients with inoperable tumor and patients undergoing neo-adjuvant chemotherapy
- Patients with diagnosis by FNA cytology
- Pregnant or lactating women
- Prior therapy for breast cancer, including irradiation, chemo-, immuno- and/or hormonal therapy
- Patients receiving any hormonal therapy, e.g., birth-control pills, ovarian hormonal replacement therapy, infertility medications, etc. are not eligible
- Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patients from being subjected to surgical excision
- Psychiatric or addictive disorders that would preclude obtaining informed consent
- Patients known or suspected to have hypercoagulable syndrome or history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism
- Women who are post-menopausal defined as no menses for at least 12 months
- Women on selective serotonin reuptake inhibitors (SSRI) SSRI inhibits metabolism of tamoxifen
- Women with non-invasive disease or microinvasion are not eligible
- Women undergoing neoadjuvant chemotherapy are not eligible
- Women currently on tamoxifen for prevention are not eligible
- Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh.
- Patients with a known mutation in p53 (Li Fraumeni Syndrome)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027416
Contacts
| Contact: AskRPCI | 1-877-275-7724 | AskRPCI@roswellpark.org |
Locations
| United States, New York | |
| Roswell Park Cancer Institute | Recruiting |
| Buffalo, New York, United States, 14263 | |
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
| Principal Investigator: | Stephen Edge, MD | Roswell Park Cancer Institute |
More Information
No publications provided
| Responsible Party: | Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01027416 History of Changes |
| Other Study ID Numbers: | RPCI I 110907, R21CA137635-01A1 |
| Study First Received: | December 4, 2009 |
| Last Updated: | January 15, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
ER positive Tamoxifen |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Tamoxifen Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Selective Estrogen Receptor Modulators Estrogen Receptor Modulators Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Bone Density Conservation Agents Estrogen Antagonists |
ClinicalTrials.gov processed this record on May 23, 2013