Analyzing a New Mechanism in Response to Tamoxifen Therapy in Breast Cancer Patients

NCT01027416 | Completed Results DMC

• 2 other identifiers: RPCI I 110907R21CA137635-01A1
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 2

Brief Summary

This study will help to understand the interaction between estrogen receptor-alpha (ER alpha) and tumor suppressor protein p53 as well as impact on patient tumor gene expression in response to the hormonal therapy Tamoxifen. This information may eventually help select the appropriate therapy for future patients with similar cancer.

Conditions

Breast Cancer

Keywords

ER positive; Tamoxifen

Outcome Measures

Primary Outcomes (1)

• Mean Percent Positive Proximity Ligation Assays of All Tumor Protein p53-wild Type Breast Tumors in Participants by Treatment Arm

  Status of estrogen receptor alpha (ERά) and tumor protein (p53) interaction in p53-wild type breast tumors in untreated patients verses patients treated with tamoxifen. Mean percent positive polylactide (PLA) of all p53-wild type breast tumors in participants by treatment arm

  2 years

Secondary Outcomes (1)

• Total Number of Over-expressed Genes, Across All Participants With Tumor Protein p53-wild Type Breast Tumors That Had RNA Samples Available.

  2 years

Study Arms (2)

No Intervention

NO INTERVENTION

Tamoxifen

ACTIVE COMPARATOR

Tamoxifen 20 mg orally 1x/day for 4 weeks

Drug: Tamoxifen

Interventions

Tamoxifen DRUG

Drug: Tamoxifen 20 mg orally 1x/day for 4 weeks

Tamoxifen

Eligibility Criteria

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

You may qualify if:

• 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 ER-apha receptor positive
• The tumor should be approximately at least 1 cm, to account for variability in imaging and imaging occult disease (physical exam, mammography, ultrasound). We recognize that from time to time because of this variation, there might not be enough tissue available for analysis after surgical excision but this will allow the greatest opportunity to capture as many eligible patients as possible.
• Patients in whom surgical excision of the tumor is part of standard of care management
• ECOG score of 0 or 1
• Negative serum or urine beta-hCG pregnancy test at screening for patients of child-bearing potential (this is routinely done if the patient is premenopausal and having surgery)
• Consent to participate in DBBR (RPCI only)

You may not qualify if:

• Male patients are not eligible for this study
• Female patients with inoperable tumors or women with stage 4 disease diagnosed on CT, PET, PET/CT or bone scan.
• Patients with diagnosis by FNA cytology only
• Pregnant or lactating women
• Prior therapy for breast cancer, including irradiation, chemo- immuno- and/or hormonal therapy
• Patients receiving any hormonal therapy, e.g. ovarian hormonal replacement therapy, infertility medications etc., are not eligible
• Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude the patient 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 with history of venous or arterial thrombosis, stroke, TIA, or pulmonary embolism
• Women with non-invasive disease or microinvasion are not eligible.
• Women undergoing neoadjuvant chemotherapy are not eligible
• women currently on tamoxifen and raloxifene 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)

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Chicago

Chicago, Illinois, 60601, United States

Location

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

Related Publications (1)

• Oturkar CC, Rosario SR, Hutson AD, Groman A, Edge SB, Morrison CD, Swetzig WM, Wang J, Park JH, Kaipparettu BA, Singh PK, Kumar S, Cappuccino HH, Ranjan M, Adjei A, Ghasemi M, Goey AKL, Kulkarni S, Das GM. ESR1 and p53 interactome alteration defines mechanisms of tamoxifen response in luminal breast cancer. iScience. 2024 May 15;27(6):109995. doi: 10.1016/j.isci.2024.109995. eCollection 2024 Jun 21.

  PMID: 38868185 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Senior Administrator, Compliance - Clinical Research Services
• Organization: Roswell Park Cancer Institute

716-845-2300

Study Officials

• Gokul Das, PhD

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2009
• First Posted: December 8, 2009
• Study Start: December 14, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 21, 2026
• Results First Posted: December 13, 2017

Record last verified: 2026-03

Locations

US (2)