Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2023-05-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.

PURPOSE: This phase II trial is studying how well tamoxifen citrate works in patients with metastatic or recurrent breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Cooperative Oncology Group
• Collaborator: National Cancer Institute (NCI)
• Treatments: Citric Acid; Tamoxifen

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast

• Stage III (locally advanced), metastatic, or recurrent disease

• Deemed not resectable

• Estrogen-receptor and/or progesterone-receptor positive disease

• Receptor status is based on most recent results

• Receptor testing on metastatic disease is not required

• Measurable or non-measurable disease

• History of CNS metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms

• No known leptomeningeal disease allowed

PATIENT CHARACTERISTICS:

• ECOG performance status 0-2

• Menopausal status not specified

• Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

• ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective nonhormonal contraception

• No medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities

• More than 5 years since prior invasive malignancies except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior investigational agents in the metastatic setting

• Other prior investigational agents in any setting must have been completed at least 6 weeks prior to study registration and should be discussed with the study PI

• Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose

• Prior tamoxifen for advanced disease is not allowed

• No prior chemotherapy or trastuzumab (Herceptin) for metastatic disease

• Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy

• Patients must not have had more than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics

• Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation

• Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting

• At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:

• Paroxetine (Paxil)

• Fluoxetine (Prozac)

• Bupropion (Wellbutrin)

• Quinidine (Cardioquin)

• Patients may not initiate bisphosphonate therapy while receiving treatment on this study

• Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration

• Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:

• Radiotherapy was initiated before study entry

• Sites of measurable or non-measurable disease are outside the radiotherapy port

• Recovered from prior radiotherapy

• No other concurrent hormonal therapy

• No concurrent chemotherapy