CLINICAL TRIAL

Rapamycin for Breast Cancer

Waitlist Available · 18+ · Female · San Antonio, TX

This study is evaluating whether a drug may help reduce the number of cancerous cells in breast tissue.

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About the trial for Breast Cancer

Eligible Conditions
Breast Cancer · Breast Neoplasms

Treatment Groups

This trial involves 2 different treatments. Rapamycin 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.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Rapamycin
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sirolimus
FDA approved

Side Effect Profile for Rapamycin Group

Rapamycin Group
Show all side effects
pneumonia
31%
acute kidney failure
15%
total abdominal hysterectomy and salpingectomy
8%
anemia
8%
dehydration
8%
hip replacement
8%
acute rejection
8%
This histogram enumerates side effects from a completed 2009 Phase 4 trial (NCT00223678) in the Rapamycin Group ARM group. Side effects include: pneumonia with 31%, acute kidney failure with 15%, total abdominal hysterectomy and salpingectomy with 8%, anemia with 8%, dehydration with 8%.

Eligibility

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

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Women with confirmed menopausal status. All patients who have NOT had a prior bilateral oophorectomy and/or are younger than age 60, will require menopausal status verified by FSH and estradiol local labs.
Women of child-bearing potential willing to practice 2 forms of contraception, one of which must be a barrier method until at least 30 days after the last dose of rapamycin.
Patients must be able to swallow and retain oral medication.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: A tissue sample will be collected 10 days after rapamycin dose for analysis.
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: A tissue sample will be collected 10 days after rapamycin dose for analysis..
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Rapamycin will improve 1 primary outcome and 4 other outcomes in patients with Breast Cancer. Measurement will happen over the course of A tissue sample will be collected 10 days after rapamycin dose for analysis..

The effect of short-term rapamycin treatment on the presence or absence of necrosis
A TISSUE SAMPLE WILL BE COLLECTED 10 DAYS AFTER RAPAMYCIN DOSE FOR ANALYSIS.
The effect of short-term rapamycin treatment on sphere regeneration frequency in serial passages
A TISSUE SAMPLE WILL BE COLLECTED 10 DAYS AFTER RAPAMYCIN DOSE FOR ANALYSIS.
The effect of short-term rapamycin treatment on luminal-to-basal epithelial ratio
A TISSUE SAMPLE WILL BE COLLECTED 10 DAYS AFTER RAPAMYCIN DOSE FOR ANALYSIS.
The effect of short-term rapamycin treatment on basal and luminal stem/progenitor cell frequency
A TISSUE SAMPLE WILL BE COLLECTED 10 DAYS AFTER RAPAMYCIN DOSE FOR ANALYSIS.
The effect of short-term rapamycin treatment on tumor grade and biomarkers associated with progression to invasive breast cancer
TISSUE SAMPLES WILL BE COLLECTED 10 DAYS AFTER RAPAMYCIN DOSE FOR ANALYSIS.

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?

Approximately 1.7 million women will be diagnosed a year with breast cancer in the years 2017-2019. The burden of breast cancer in the United States remains disproportionate to the incidence of breast cancer.

Anonymous Patient Answer

What are the signs of breast cancer?

Signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) that can be evaluated during assessment of patient presentation include: palpable breast masses, ulcers, and a palpable lump that cannot be felt with gloved hands. Nodal disease is indicated by an enlarged lymph node and the presence of a fluid-filled cyst.

Anonymous Patient Answer

What are common treatments for breast cancer?

There tends to be a common treatment for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in most parts of the world. Findings from a recent study found evidence of an emphasis on the use of endocrine therapies (including trastuzumab), as well as chemotherapy and radiotherapy for both localized and advanced breast cancer. Findings from a recent study also found that there appears to be an emphasis on the use of palliative care and hospice, as a way of caring for those patients who develop secondary physical symptoms from the cancer or from the treatment itself.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is a disease that forms in the breast tissues and causes uncontrolled cell growth. It is the most common form of cancer in women worldwide.\n

Anonymous Patient Answer

Can breast cancer be cured?

While the cancer itself cannot be cured, the symptoms of breast cancer can be tackled and minimized with successful treatment, providing patients with optimum support through complementary treatment interventions. This may allow the survivors of breast cancer to live a full life.

Anonymous Patient Answer

What causes breast cancer?

There is a small change in risk of breast cancer for a female child compared with a sibling; however children born after 1971 were at a slightly higher risk.\n

Anonymous Patient Answer

Have there been other clinical trials involving rapamycin?

Although rapamycin has been used as an investigational therapy in numerous clinical trials for a variety of indications, the results reported from other clinical trials conducted in vivo in this context have shown that systemic exposure to this compound is extremely limited. Results from a recent clinical trial of our trial, which investigated the effects of rapamycin on the growth of xenograft tumors in a [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) xenograft model, implicate it as an attractive candidate for clinical testing for various cancers. Results from a recent clinical trial support the hypothesis that rapamycin is an active inhibitor of mTORC1 and suggest that rapamycin may have the potential to be used as anti-cancer therapy in treating BCLC stage C BCLC B2 tumors characterized by elevated expression of mTOR.

Anonymous Patient Answer

How serious can breast cancer be?

While many clinicians view breast cancer as a manageable benign disorder, this is not the case. The current paradigm for managing breast cancer fails to adequately consider the seriousness of the disease. Furthermore, recent recommendations in support of aggressive therapies in patients with a new diagnosis indicate that these agents, such as docetaxel, should be avoided in patients with metastatic breast cancer. Because of these findings, we developed and validated the seriousness of breast cancer scale for routine use in clinical practice to help inform patients, providers, and their families regarding the prognosis and potential treatment options for breast cancer. The seriousness scale also allows for a standardization or calculation of risk factors that predict disease course and, thereby, individualized decisions on breast cancer therapy.

Anonymous Patient Answer

Has rapamycin proven to be more effective than a placebo?

Results from a recent paper provide evidence that rapamycin treatment of breast cancer patients results in increased tumor cell arrest and apoptosis, and longer PFS. Thus, rapamycin may provide a new therapeutic approach, either alone or in combination with other anticancer agents, to the treatment of breast cancer patients.

Anonymous Patient Answer

What are the chances of developing breast cancer?

The odds of developing breast cancer at any given age depend on the number of people with breast cancer that have had the disease at that age. There are a number of factors that determine the chances of being diagnosed with breast cancer. These factors include age, the number of mammograms one has had, the amount of time spent exercising, and family history of breast cancer.\n

Anonymous Patient Answer

What is the survival rate for breast cancer?

There is a significant survival discrepancy between breast cancer subtypes. The most common reason for inferior outcomes in breast cancer is tumor size >2 cm. Although women with smaller tumors did have longer disease-free intervals (mean years: 15.4; 5-22 years), larger tumors showed substantially superior 5-year disease-free survival. A subcutaneous approach improves surgical margins but has no significant effect on disease-free time.

Anonymous Patient Answer

Who should consider clinical trials for breast cancer?

Clinical trials provide a unique opportunity for patients who have exhausted other treatment options and who hope they may benefit from a new drug or more intensive therapy.

Anonymous Patient Answer
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