everolimus for Breast Cancer

Phase-Based Estimates
2
Effectiveness
3
Safety
NYP/Weill Cornell Medical Center, New York, NY
Breast Cancer+1 More
everolimus - Drug
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

This study is evaluating whether hormone therapy is more effective when given with or without everolimus in treating patients with breast cancer.

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Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether everolimus will improve 1 primary outcome and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of over 10 years.

over 10 years
DRFS, assessed up to 10 years
IDFS using a stratified log-rank test, assessed up to 10 years
OS estimates will be based on Kaplan-Meier procedures, assessed up to 10 years
Toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, assessed up to 10 years

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Arm I
Arm II
Placebo group

This trial requires 1900 total participants across 2 different treatment groups

This trial involves 2 different treatments. Everolimus is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Arm IIPatients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
Arm IPatients receive an approved endocrine therapy comprising tamoxifen citrate*, goserelin acetate** or leuprolide acetate**, or an aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo PO daily for 1 year in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leuprolide
FDA approved
Anastrozole
FDA approved
Exemestane
FDA approved
Goserelin
FDA approved
Tamoxifen
FDA approved
Letrozole
FDA approved
Everolimus
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: over 10 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly over 10 years for reporting.

Closest Location

NYP/Weill Cornell Medical Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The HER2 test result negativity must be assessed using IHC, ISH, or both according to the ASCO/CAP 2013 guidelines. show original
Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast or more than one lesion in different quadrants. show original
ISH is not required if IHC is negative with a single probe or dual probe show original
Patients with invasive breast cancer who are positive for estrogen and/or progesterone receptors and negative for human epidermal growth factor receptor 2 are candidates for standard adjuvant endocrine therapy. show original
in ≥ 10% of tumor cells or by immunohistochemistry (IHC) using validated antibodies with a reported sensitivity of at least 90% (level of evidence: 1B) To be classified as ER+ or PR+ a tumor must have positive nuclear staining in at least 10% of tumor cells, or be assessed by IHC using validated antibodies with a reported sensitivity of at least 90%. show original
If your HER2 result is equivocal, you are not eligible to take part in this study. show original
IHC negative (0 or 1+)
Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed
Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other

Patient Q&A Section

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

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

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Approximately 275,000 new cases of breast cancer are diagnosed in the US each year. About 75,000 women in the US are diagnosed with breast cancer per year. Of the 275,000 cases of breast cancer in the US yearly, roughly 2,000 cases are reported fatal. About 1,200 deaths are reported yearly from breast cancer in the US. Approximately 50 cases will be diagnosed in Washington D.C. per year. About 25 cases of breast cancer will be diagnosed in Virginia each year. About 1,000 women will be diagnosed with breast cancer in Arkansas each year. About 100 cases will be diagnosed per year in Washington D.C. About 70 cases arise in Massachusetts. About 10 cases will be diagnosed in Texas.

Unverified Answer

What are common treatments for breast cancer?

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Breast cancer treatment is largely reliant on the patient's stage of cancer. The specific treatments used may be chemotherapy, hormone therapy, radiation therapy, surgery or a combination of these treatments.\n

Unverified Answer

What causes breast cancer?

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Risk factors for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include nulliparity, breastfeeding, hormone imbalance and certain genetic mutations such as "BRCA 1 and BRCA 2". Most of breast cancer is not caused by genetic mutations though the tumour may develop at a rapid rate, which could be caused by hormonal imbalance, environmental conditions, and the presence of tumour suppressor genes. Breast cancer is currently treated by surgery, chemotherapy, and antiestrogen drugs. The most effective treatment is the combination of estrogen agonists with tamoxifen. While surgery may be considered in older women and women who are unfit for chemo or hormone therapy, there is no convincing evidence supporting aggressive surgery in younger women who are cured of breast cancer by surgery alone.

Unverified Answer

What are the signs of breast cancer?

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Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can be physical examination findings such as a palpable lump or a lump while breast-feeding, a mass in the axilla, discharge from the nipple, nipple retraction, and a family history of breast cancer. A physical examination of the abdomen or the pelvic area may reveal masses in the organs and may also show bowel obstruction. A colonoscopy may reveal masses (masses of colon cancer in the colon) which may compress the bowel.\n

Unverified Answer

What is breast cancer?

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Breast cancer is the most common type of cancer in women and the most common form of cancer overall in cancer centers that accept women in Massachusetts. In the US, breast cancer claims the life of at least one woman each day. The US incidence and mortality rates of breast cancer have risen steadily since their lowest values in 1969.

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Can breast cancer be cured?

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The only way for an individual to have a cure for their own [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is to eliminate the causative tumor and it's micro-metastases in all of the tissues that are under a woman's control. In fact, all women with early breast cancer are curable with early excisional surgery, which is curative in almost all cases. The disease, though, still can relapse after excision; the best method of avoiding a relapse is to use effective treatments, such as breast-conserving therapy (BCT) to remove the tumor and hopefully all local (within the breast tissue) micro-metastases, followed by adjuvant radiotherapy and chemotherapy, and/or endocrine therapy.

Unverified Answer

Have there been other clinical trials involving everolimus?

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Everolimus, as a single agent and in combination with exemestane in patients with HR-positive locally advanced or metastatic ER/PR-positive tumors, did not demonstrate the effectiveness of everolimus for either progression-free survival or overall survival in two phase III trials (NCT00362968 and NCT00121684) at 16-month treatment completion. For patients with ER/PR-positive breast cancer treated with anastrozole plus exemestane for at least 12 months, everolimus was observed to have a significant impact on progression-free survival and is currently being studied in the HER2-expressing subgroup (NCT01159950).

Unverified Answer

What is everolimus?

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After four months of everolimus or everolimus/exemestane, women are more likely to have a complete resolution of enlarged lymph nodes. They are also more likely to have a complete or partial response, as evidenced by a reduction in the size of or the number of residual lymph nodes by palpation. Patients who have a complete response (≥75% shrinkage in lymph nodes) derive a similar survival benefit when switching to everolimus. Additionally, after 10-12 weeks of everolimus, patients are more likely to have fewer residual lymph nodes compared with patients who receive placebo.

Unverified Answer

What are the common side effects of everolimus?

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Among patients treated with everolimus, the most commonly reported side effect of everolimus is fatigue. Other commonly reported side effects include cough, anemia, hyponatremia, and decreased appetite. These side effects of everolimus seemed to occur at some point during everolimus therapy and were not serious.

Unverified Answer

Who should consider clinical trials for breast cancer?

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While the current generation of treatments may not be an optimal option (particularly in the case of chemotherapy and newer therapies), and current clinical trials have not always reported results of superior effectiveness to treatment observed in the general population (especially in the case of aromatase inhibitors), there are numerous patients who suffer from the adverse effects of treatments and who wish to try alternatives. Because in most countries with sufficient resources, physicians have access to clinical trials comparing alternative therapies for the treatment of breast cancer, and because the results of clinical trials are published and available to other physicians, many patients use available information in order to make treatment choice. However, patients should be cautious in assessing the benefits and risks of clinical research prior to embarking on a clinical trial.

Unverified Answer

What is the latest research for breast cancer?

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In order to summarize the most important information, I’ve listed the research we used in each category. Each time, I’m going to update the table. If you are a breast cancer patient you’re welcome to send me a message. If it doesn’t contain critical content please send me a picture and a message.\n

Unverified Answer

Does breast cancer run in families?

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Although family history does occur in breast cancers, this is not a strong predictor of breast cancer risk. Genetic predisposition certainly plays a role, but in this small series, it did not account for the occurrence of more tumors, and the number was not statistically significant. Future studies examining this question should have higher confidence levels to overcome confounding factors.

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