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Tamoxifen Citrate in Treating...

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Last Updated: 2023-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-07

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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OBJECTIVES:

Primary

* To correlate CYP2D6 (Cytochrome P450 2D6) score (0 vs 1-2) and progression-free survival (PFS)

Secondary

* To correlate CYP2D6 score (0 vs 1 vs 2) and PFS
* To correlate CYP2D6 score (0 vs 1-2) and the proportion of these patients who are progression-free at 6 months.
* To correlate endoxifen concentration with response
* To correlate CYP2D6 with response
* To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UDP-glucuronosyltransferases (UGT) 7, sulfotransferases (SULT) 1A1, other candidate genes and biomarkers to PFS and other tamoxifen related outcomes

OUTLINE: This is a multicenter study.

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.

Blood, plasma, and tissue samples are collected periodically for laboratory studies.

After completion of study therapy, patients are followed up every 3-6 months for 5 years.

Conditions

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Breast Cancer Stage IV Breast Cancer

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tamoxifen

Patients receive oral tamoxifen citrate once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.

Group Type EXPERIMENTAL

tamoxifen

Intervention Type DRUG

Interventions

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tamoxifen

Intervention Type DRUG

Other Intervention Names

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tamoxifen citrate Nolvadex NSC# 180973

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vered Stearns, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

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UAB Comprehensive Cancer Center

Birmingham, Alabama, United States

Site Status

University of South Alabama Mitchell Cancer Institute

Mobile, Alabama, United States

Site Status

Hembree Mercy Cancer Center at St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Site Status

Tibotec Therapeutics - Division of Ortho Biotech Products, LP

Marysville, California, United States

Site Status

Mercy Cancer Center at Mercy Medical Center

Merced, California, United States

Site Status

Camino Medical Group - Treatment Center

Mountain View, California, United States

Site Status

St. Joseph Hospital Regional Cancer Center - Orange

Orange, California, United States

Site Status

Palo Alto Medical Foundation

Palo Alto, California, United States

Site Status

Valley Medical Oncology Consultants - Pleasanton

Pleasanton, California, United States

Site Status

University of California Davis Cancer Center

Sacramento, California, United States

Site Status

Tahoe Forest Cancer Center

Truckee, California, United States

Site Status

Aurora Presbyterian Hospital

Aurora, Colorado, United States

Site Status

Boulder Community Hospital

Boulder, Colorado, United States

Site Status

Penrose Cancer Center at Penrose Hospital

Colorado Springs, Colorado, United States

Site Status

St. Anthony Central Hospital

Denver, Colorado, United States

Site Status

Porter Adventist Hospital

Denver, Colorado, United States

Site Status

Presbyterian - St. Luke's Medical Center

Denver, Colorado, United States

Site Status

St. Joseph Hospital

Denver, Colorado, United States

Site Status

Rose Medical Center

Denver, Colorado, United States

Site Status

CCOP - Colorado Cancer Research Program

Denver, Colorado, United States

Site Status

Swedish Medical Center

Englewood, Colorado, United States

Site Status

St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center

Grand Junction, Colorado, United States

Site Status

North Colorado Medical Center

Greeley, Colorado, United States

Site Status

Littleton Adventist Hospital

Littleton, Colorado, United States

Site Status

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Site Status

Hope Cancer Care Center at Longmont United Hospital

Longmont, Colorado, United States

Site Status

McKee Medical Center

Loveland, Colorado, United States

Site Status

Parker Adventist Hospital

Parker, Colorado, United States

Site Status

St. Mary - Corwin Regional Medical Center

Pueblo, Colorado, United States

Site Status

North Suburban Medical Center

Thornton, Colorado, United States

Site Status

Exempla Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Middlesex Hospital Cancer Center

Middletown, Connecticut, United States

Site Status

Yale Cancer Center

New Haven, Connecticut, United States

Site Status

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, United States

Site Status

CCOP - Christiana Care Health Services

Newark, Delaware, United States

Site Status

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

Washington Cancer Institute at Washington Hospital Center

Washington D.C., District of Columbia, United States

Site Status

Broward General Medical Center Cancer Center

Fort Lauderdale, Florida, United States

Site Status