Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer
Condition: Breast Cancer; Stage IV Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: tamoxifen
Intervention description: PO
Intervention MeSH terms: Tamoxifen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 124.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: estrogen receptor-positive breast cancer; progesterone receptor-positive breast cancer; recurrent breast cancer; stage IV breast cancer

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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

          -  Measurable or non-measurable disease

          -  ECOG performance status 0-2

          -  History of central nervous system (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

          -  Total bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 times ULN (≤ 5 times
             ULN if liver metastases present)

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception

          -  Disease-free of prior invasive malignancies for ≥ 5 years with the exception of
             curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in
             situ of the cervix

          -  Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed
             provided it has been completed ≥ 4 weeks before study therapy; other prior
             non-hormonal investigational agents in the adjuvant setting must have been completed
             at least 4 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

          -  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)

          -  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

        Exclusion Criteria:

          -  Pregnant or nursing

          -  Concurrent chemotherapy

          -  Leptomeningeal disease

          -  Non-protocol concurrent hormonal therapy

          -  Medical or psychiatric conditions that would interfere with protocol compliance, the
             ability to provide informed consent, assessment of response, or anticipated toxicities

          -  Prior tamoxifen for advanced disease

          -  More than 2 lines of non-hormonal treatment in the locally advanced or metastatic
             setting, including trastuzumab (Herceptin), bevacizumab, or other biologics

          -  Starting 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