What side effects are associated with this type of intervention?

Common treatments for breast cancer involving endocrine therapy, such as tamoxifen and aromatase inhibitors, have distinct side effect profiles. Tamoxifen, typically administered at 20 mg daily, can cause hot flashes, vaginal discharge, and an increased risk of thromboembolic events. Lower doses (e.g., 10 mg every other day) may reduce these side effects but are supported by limited data. Aromatase inhibitors, like anastrozole, are alternatives for postmenopausal women and can lead to bone density loss, fractures, and cardiovascular risks. Both treatments aim to reduce recurrence but require careful management of their side effects.

What prior FDA approvals exist?

Endocrine therapies for breast cancer that modulate estrogen receptors have seen several FDA approvals. Tamoxifen, a selective estrogen receptor modulator (SERM), was one of the first to be approved and is widely used for both early and advanced hormone receptor-positive breast cancer. Aromatase inhibitors such as anastrozole, letrozole, and exemestane are also FDA-approved and are primarily used in postmenopausal women to reduce estrogen levels, thereby inhibiting cancer growth. These treatments have been shown to be effective in various stages of breast cancer, including metastatic cases.

What other types of research exist?

Promising novel alternatives to endocrine therapy for breast cancer patients include the use of targeted therapies such as PARP inhibitors (e.g., olaparib, talazoparib) for patients with germline BRCA mutations, and the combination of endocrine agents with mechanistic target of rapamycin (mTOR) inhibitors (e.g., everolimus). Additionally, nonhormonal agents like newer antidepressants are being explored for symptom management.

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Hormone Therapy

Endocrine Therapy for Low-Risk Breast Cancer

Phase 2

Recruiting

Led By Rebecca L Aft, M.D, Ph.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG performance status ≤ 3

Disease must be ER+ and HER2-

Must not have

Prior surgery for this cancer

A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if hormone therapy alone can effectively treat breast cancer in women aged 70 or older with certain types of tumors. The therapy works by blocking estrogen, which helps stop cancer cells from growing. Researchers believe this approach could be enough to control the cancer without needing more aggressive treatments.

Who is the study for?

This trial is for women aged 70 or older with a specific type of breast cancer that's sensitive to hormones and hasn't spread widely (ER+ operable invasive breast cancer, cT1 or T2, N0-1, M0). Participants should have low levels of a protein called Ki67, be able to perform daily activities with some limitations (ECOG ≤ 3), and not have had previous surgery for this cancer. Women with HIV on antiretroviral therapy, other recent cancers, or severe illnesses are excluded.

What is being tested?

The study tests if endocrine therapy alone can control breast cancer in elderly women without the need for surgery. It involves treatments like Fulvestrant, Tamoxifen, Anastrozole, Exemestane and Goserelin. The effectiveness will be measured by changes in tumor size using ultrasound or mammogram and quality of life assessments.

What are the potential side effects?

Endocrine therapies may cause hot flashes, joint pain, fatigue, mood swings and slight nausea. Rarely they might affect bone density leading to osteoporosis over time. Each medication has its own set of potential side effects which will be monitored closely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am capable of only limited self-care, confined to my bed or chair more than 50% of waking hours.

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My cancer is estrogen receptor positive and HER2 negative.

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I am 70 years old or older.

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I have been newly diagnosed with early-stage breast cancer that can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had surgery for my cancer.

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I have had another cancer within the last 5 years that would interfere with hormone therapy for my current cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Endocrine therapy aloneExperimental Treatment7 Interventions

* Neoadjuvant endocrine therapy will be given at the discretion of the treating physician as directed by the package insert and could include the following: goserelin, anastrozole, letrozole, exemestane, fulvestrant, or tamoxifen * Frequency of office visits will be decided by the treating physician but must occur no less frequently than every 3 to 6 months for tumor assessment * After 6 months and after 12 months, patients will be assessed; patients who progress will have standard care recommended , and at any point a patient can opt to receive standard care even if she has not progressed on neoadjuvant endocrine therapy * Information on quality of life will be collected at baseline, Year 1, and Year 2 by the FACT-B questionnaire * Archival tissue will be collected and sent to Genomic Health for analysis using the Oncotype DX assay. The Recurrence Score predicts chemotherapy benefit and indicates the 10-year risk of recurrence (will not be used to determine treatment)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3510

Tamoxifen

2005

Completed Phase 4

~30110

Anastrozole

2016

Completed Phase 4

~5550

Exemestane

2003

Completed Phase 4

~7510

Goserelin

2008

Completed Phase 3

~4270

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Endocrine therapy for breast cancer primarily involves hormonal modulation of estrogen receptors to inhibit the growth of ER+ tumors. Common treatments include selective estrogen receptor modulators (SERMs) like tamoxifen, which block estrogen receptors on cancer cells, and aromatase inhibitors (AIs) such as anastrozole and letrozole, which reduce estrogen production in postmenopausal women. These therapies are crucial for patients with ER+ breast cancer as they target the hormone-driven growth of cancer cells, potentially reducing recurrence and improving survival rates without the severe side effects associated with chemotherapy.