Bazedoxifene and Conjugated Estrogens for Breast Cancer

Phase-Based Estimates
1
Effectiveness
2
Safety
City of Hope Medical Center, Duarte, CA
Breast Cancer+2 More
Bazedoxifene and Conjugated Estrogens - Drug
Eligibility
18 - 65
Female
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether a drug may help reduce the risk of breast cancer in women who are at risk for developing the disease.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Risk Reduction

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Bazedoxifene and Conjugated Estrogens will improve 1 primary outcome, 1 secondary outcome, and 2 other outcomes in patients with Breast Cancer. Measurement will happen over the course of baseline to 6 months.

baseline to 6 months
Change in FGV
Change in blood hormones
Change in proliferation
baselne to 6 months
change in gene expression

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Bazedoxifene plus conjugated estrogens immediately

This trial requires 120 total participants across 2 different treatment groups

This trial involves 2 different treatments. Bazedoxifene And Conjugated Estrogens is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Bazedoxifene plus conjugated estrogens immediately
Drug
BZA (20 mg) plus CE (0.45 mg) taken together once daily for 6 months, commencing immediately.
ControlNo treatment in the control group

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baselne to 6 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baselne to 6 months for reporting.

Who is running the study

Principal Investigator
C. F.
Prof. Carol Fabian, MD
University of Kansas Medical Center

Closest Location

City of Hope Medical Center - Duarte, CA

Eligibility Criteria

This trial is for female patients between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Women age 45 - 60.
Current vasomotor symptoms (hot-flashes, night sweats or both). These do not need to be frequent or severe but should occur at least once a week. Women who feel that they would likely need a supplement or be at high risk of withdrawal if they were randomized to waitlist because of vasomotor symptoms are not good candidates for this trial.
Women must be in one of the four menopausal status categories, as defined below.
Category 1: Clinically Postmenopausal. Age 45-60 with an intact uterus and no periods in past 12 months. Amenorrhea is not thought to be due to endometrial ablation, Mirena IUD or other menses suppressing contraceptives. No pre-study FSH is required.
Category 2: Late menopause transition. Age 45-60 with an intact uterus and no periods in past 2 months immediately preceding eligibility testing; but has not been amenorrheic for 12 months. Amenorrhea not thought to be due to endometrial ablation, Mirena IUD or other menses suppressing contraceptives. No pre-study FSH is required.
Category 3: Menopause status cannot be determined by menstrual history; age ≥50. Age 50-60 and prior hysterectomy, prior endometrial ablation with subsequent lack of periods, or menses suppression due to Mirena IUD or other types of contraceptives. No pre-study FSH is required.
Category 4: Menopausal status cannot be accurately determined by menstrual history; age 45-49. Age 45-49 and prior hysterectomy, prior endometrial ablation with subsequent lack of periods, or menses suppression due to Mirena IUD or other types of contraceptives. A pre-study FSH is required and must be ≥25 mIU/ml or in postmenopausal range by institutional laboratory standard.
Must have at least one ovary.
BMI: ≤ 35 kg/m2
A mammogram and a fine needle aspiration of the breast is performed. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is breast cancer?

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Breast cancer is a malignant disease of the breast tissue in which a cancer's cells grow in large clusters and invade the surrounding breast or neighboring tissues. It accounts for 5% of all newly diagnosed cancer cases. Older women and women who have never had a child have about 5% higher risk. Breast cancer has a 5-year survival rate of 88%, and mortality rate is about 14%.

Unverified Answer

What are common treatments for breast cancer?

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The most common treatment is mastectomy, followed by chemotherapy plus tamoxifen (TAM). Other treatments include breast-conserving therapy, radiation, chemotherapy, chemotherapy plus tamoxifen and trastuzumab. There is a great deal of evidence supporting the best use of adjuvant therapy, that is, chemotherapy and/or radiotherapy to manage and treat [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The American College of Surgeons Practice Patterns Committee, American College of Surgeons National Quality Forum, and the American Cancer Society recommend that adjuvant treatment be considered in node-negative breast cancer and for all women with at least one node negative breast in the sentinel lymph node.

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What causes breast cancer?

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Breast cancer is more common in some geographic locations than other geographic locations. Also, women who developed breast cancer were more likely than their female peers not to consume milk or have had mammae, which may explain why the women seem to be less affected by breast cancer. Breast cancer can have several causes, including genetics and external factors.\n

Unverified Answer

What are the signs of breast cancer?

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Most women are not aware of their signs of cancer. However, most women are aware of breast cancer symptoms such as nipple soreness. It is important to know how signs of cancer can influence a woman's behavior. The signs can be used to assess breast cancer risks and may help the patient and their physician make a decision about the likelihood of relapse.

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How many people get breast cancer a year in the United States?

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About 4 million women will be diagnosed with breast cancer during their lifetime, and 3 million will be diagnosed after age 70. The lifetime risk of getting breast cancer is 13% for white women and 3% for African American women.

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Can breast cancer be cured?

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Although many patients with sporadic breast cancer and even some in the BRCA families do not have symptoms at the time, many develop symptoms in later life. With modern treatment, breast cancer cannot be cured.

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What is bazedoxifene and conjugated estrogens?

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This article describes two very different compounds which, in vitro or in clinical studies, act on the same cellular targets in a synergistic way: bazedoxifene and conjugated estrogens. Because both compounds modulate the target proteins differently, this should be taken into account by the medical staff prescribing the agents and the patients involved before a joint action is carried out.

Unverified Answer

How quickly does breast cancer spread?

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A small number of patients may develop [metastatic [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer)](https://www.withpower.com/clinical-trials/metastatic-breast-cancer) from a first screen-detection of small breast cancer lesions, but the majority develop distant metastase from clinically and biologically early stage disease. The small risk of cancer in the ipsilateral breast on mammography or ultrasonography must be weighed against the potentially destructive nature of overt breast mass or the need for diagnostic evaluation and treatment.

Unverified Answer

Have there been any new discoveries for treating breast cancer?

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There was limited evidence of improvement in outcomes for those who used alternative cancer treatments. The evidence for alternative treatments for breast cancer remains inconclusive. Further investigation should be directed at further defining the efficacy of alternative treatments, which may entail implementing clinical trials.

Unverified Answer

What is the average age someone gets breast cancer?

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This is the oldest cohort described in the world to be tested for BRCA1 or BRCA2 germline mutations. In our cohort of family members who reported no history of breast or [ovarian cancer](https://www.withpower.com/clinical-trials/ovarian-cancer), the mean age at diagnosis was 62 years (range: 49-68 years). An average of 24% of individuals had multiple family members with cancer; family history did not correlate with the number of affected relatives. This cohort did not differ from the general population in terms of age at diagnosis, sex, race, ethnicity, mammographic density, or family history of cancer. These data support an age of diagnosis at a later age in women with breast cancer when compared with age of diagnosis in the general population.

Unverified Answer

How serious can breast cancer be?

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Breast cancer has the power to destroy a woman's life. And it's a life in which she doesn't have a future. It seems that the more a woman knows beforehand, the less is her life destroyed.

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What are the common side effects of bazedoxifene and conjugated estrogens?

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After 4 weeks of therapy, side effects of estrogens were similar to those detected with placebo. However, with conjugated estrogens bazedoxifene and ethinylestradiol a statistically significant reduction of uterine bleeding was observed. No cardiovascular events was found.

Unverified Answer
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