What side effects are associated with this type of intervention?

Common treatments for breast cancer involving hormonal modulation, such as tamoxifen and aromatase inhibitors, have several known side effects. Tamoxifen can cause hot flashes, vaginal dryness or discharge, and an increased risk of blood clots and endometrial cancer. Aromatase inhibitors, like anastrozole, may lead to loss of bone density, fractures, and cardiovascular risks. Both treatments can also cause menopausal symptoms and fatigue. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several hormonal therapies for the treatment of breast cancer, particularly those that modulate estrogen receptors. Tamoxifen, a selective estrogen receptor modulator (SERM), was one of the first approved and is widely used for both treatment and prevention of breast cancer. Aromatase inhibitors such as letrozole and anastrozole are also approved for postmenopausal women, reducing estrogen production. Fulvestrant, a selective estrogen receptor down-regulator, is another option for hormone receptor-positive metastatic breast cancer. These treatments, like Conjugated Estrogens/Bazedoxifene, focus on altering the hormonal environment to inhibit cancer growth.

What other types of research exist?

Promising novel alternatives to Conjugated Estrogens/Bazedoxifene for breast cancer patients include: 1) Neurokinin 3 receptor antagonists, which have shown potential in managing hot flashes and other menopausal symptoms in clinical trials. 2) Aromatase inhibitors like anastrozole, which are effective in reducing recurrence rates in postmenopausal women with ER-positive breast cancer. 3) Selective estrogen receptor modulators (SERMs) such as tamoxifen, which continue to be a mainstay in reducing recurrence and preventing new breast cancer events. These alternatives offer different mechanisms of action and can be tailored to individual patient needs and preferences.

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Hormone Therapy

Duavee for Breast Cancer

Phase 2

Recruiting

Led By Swati Kulkarni, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

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

Must have

Women must have newly diagnosed histologically confirmed ER (+) DCIS scheduled to undergo surgical therapy

Women must be postmenopausal

Must not have

Patients with a 'currently active' second malignancy other than non-melanoma skin cancers

Any of the following conditions, or a known history of any of the following: deep venous thrombosis, pulmonary embolism, retinal vascular thrombosis, any arterial thrombosis, Known protein C, protein S, or anti-thrombin deficiency or other known thrombophilic disorders including stroke and myocardial infarction, Unexplained/undiagnosed abnormal uterine bleeding (concern for undiagnosed endometrial cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

Summary

This trial tests a treatment on women with early-stage breast cancer to see if it can reduce cancer risk by changing specific signs in breast tissue.

Who is the study for?

Postmenopausal women aged 18-79 with newly diagnosed ER (+) DCIS of the breast, scheduled for surgery. Participants must be able to swallow pills, sign consent forms, and have normal organ/marrow function. Excluded are those on certain drugs, with invasive breast cancer or other serious conditions like blood clots or active second cancers.

What is being tested?

The PROMISE Study tests if Duavee (conjugated estrogens/bazedoxifene), approved for menopause symptoms but not for DCIS in postmenopausal women, affects breast tissue markers and is safe. It includes a placebo group and examines quality-of-life impacts through questionnaires.

What are the potential side effects?

Potential side effects may include hot flashes relief-related issues since Duavee is used to treat menopause symptoms. However, as its use in DCIS is experimental, there could be unknown risks which this study aims to uncover.

Eligibility Criteria

Inclusion Criteria

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

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I am a woman with a new ER+ DCIS diagnosis planning for surgery.

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I have gone through menopause.

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I am confirmed to be postmenopausal after having a hysterectomy without removing both ovaries.

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I can take care of myself but might not be able to do heavy physical work.

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I had surgery for cancer with some cancer cells still left at the edges.

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My blood counts and liver/kidney functions are within normal ranges.

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I can swallow pills.

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I am a woman aged between 18 and 79.

Exclusion Criteria

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

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I have another active cancer besides non-melanoma skin cancer.

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I have a history of blood clots or bleeding disorders.

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I am not taking any strong medication that affects liver enzymes.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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My breast cancer has come back on the same side.

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I am not pregnant or breastfeeding.

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I have been diagnosed with invasive breast cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Ki-67 protein expression

Secondary study objectives

Breast Cancer Prevention Trial Eight Symptom Scale (BESS) questionnaire

Epithelial markers of progression

Expression of ERα

+6 more

Other study objectives

Anterior Gradient 2 (AGR2)

Estrogen-modulated genes in the breast stroma

Expression of estrogen-modulated genes in breast epithelium

+5 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (conjugated estrogens/bazedoxifene)Experimental Treatment5 Interventions

Patients receive conjugated estrogens/bazedoxifene orally (PO) once daily (QD) for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Group II: Arm II (placebo)Placebo Group5 Interventions

Patients receive placebo PO QD for 28 +/- 7 days in the absence of disease progression or unacceptable toxicity. Patients then undergo surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Quality-of-Life Assessment

2017

Completed Phase 3

~4950

0 / 15Eligibility 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

Hormonal modulation treatments for breast cancer, such as conjugated estrogens/bazedoxifene, work by altering the hormonal environment that can promote cancer growth. These treatments either block hormone receptors or reduce hormone production. For example, selective estrogen receptor modulators (SERMs) like tamoxifen bind to estrogen receptors on cancer cells, preventing estrogen from stimulating cancer growth. Aromatase inhibitors reduce estrogen levels by blocking the enzyme aromatase, which converts androgens to estrogens. These mechanisms are crucial for patients with hormone receptor-positive breast cancer, as they can significantly slow disease progression and improve survival rates by targeting the hormonal pathways that fuel cancer growth.