CLINICAL TRIAL

SV-BR-1-GM for Breast Cancer

Recruiting · 18+ · Female · Friendswood, TX

This study is evaluating whether a combination of two immunotherapy drugs may help treat breast cancer.

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About the trial for Breast Cancer

Eligible Conditions
Female Breast Neoplasms · Malignant Neoplasm of Female Breast · Breast Neoplasms

Treatment Groups

This trial involves 3 different treatments. SV-BR-1-GM is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Experimental Group 1
Interferon Inoculation
BIOLOGICAL
+
Low dose cyclophosphamide
DRUG
+
INCMGA00012
BIOLOGICAL
+
SV-BR-1-GM
BIOLOGICAL
Experimental Group 2
Interferon Inoculation
BIOLOGICAL
+
Low dose cyclophosphamide
DRUG
+
Epacadostat 600 mg BID
DRUG
+
INCMGA00012
BIOLOGICAL
+
SV-BR-1-GM
BIOLOGICAL
Experimental Group 3
Interferon Inoculation
BIOLOGICAL
+
Low dose cyclophosphamide
DRUG
+
INCMGA00012
BIOLOGICAL
+
SV-BR-1-GM
BIOLOGICAL

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Retifanlimab
Not yet FDA approved
SV-BR-1-GM
2017
Completed Phase 2
~30

Eligibility

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Breast Cancer or one of the other 2 conditions listed above. 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:
People with tumors that are positive for human epidermal growth factor 2 (HER2) and positive for estrogen receptor (ER) or positive for progesterone receptor (PR) must have refractory cancer to hormonal therapy (e.g., aromatase inhibitor, tamoxifen or fluvestrant) and must have received treatment with at least 2 different regimens in the past, including treatment with at least 2 different anti-HER2 agents (e.g., trastuzumab and pertuzumab). show original
The tumor must be resistant to hormonal therapy and have been treated with at least two chemotherapy regimens in the past. show original
Gold standard for cancer treatment is to find a therapy that works for a person's tumor show original
of study drug The brain metastases must be stable (not getting worse) for at least 4 weeks before starting the study drug. show original
The person must have received prior radiation therapy for brain metastases, or be ineligible for radiation therapy. show original
There is no need for steroids and patients have not had steroids for at least 2 weeks show original
Patients who have a persistent disease and who have a local recurrence must not be treated with local methods. show original
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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: Through study completion, an average of 1 year
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Through study completion, an average of 1 year.
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 SV-BR-1-GM will improve 4 primary outcomes and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Through study completion, an average of 1 year.

Evaluate the tumor response to SV-BR-1-GM (Non-progression) when administered in combination with INCMGA00012 and epacadostat
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Tumor response as assessed by: o Non-progressive rate, defined as CR, PR or stable disease (SD) per iRECIST
Evaluate the tumor response to SV-BR-1-GM (Durability) when administered in combination with INCMGA00012 and epacadostat
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
Tumor response as assessed by: o Durability of response
Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 and epacadostat [Safety]
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
To evaluate the safety of SV-BR-1-GM as assessed by: o Adverse Events (AEs), including Serious Adverse Events (SAEs)
Evaluate the Proportion of Patients with Abnormalities in Safety Laboratory Parameters that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 and epacadostat [Safety]
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
To evaluate the safety of SV-BR-1-GM as assessed by: o The Proportion of Patients with Abnormalities in Safety Laboratory Parameters
Evaluate changes in the electrocardiogram QT interval that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 and epacadostat [Safety]
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
To evaluate the safety of SV-BR-1-GM as assessed by: o Electrocardiograms (ECG) with measurement of the QT interval
Evaluate the changes in weight that occur in patients treated with SV-BR-1-GM administered in combination with INCMGA00012 and epacadostat [Safety]
THROUGH STUDY COMPLETION, AN AVERAGE OF 1 YEAR
To evaluate the safety of SV-BR-1-GM as assessed by: o Weight (Kg)
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Patient Q & A Section

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

Can breast cancer be cured?

There is a great deal of controversy concerning the purported curative effects of some of the various systemic therapies in the treatment of breast cancer. Some meta-analyses, systematic reviews and other studies strongly suggest that a cure for breast cancer is not available. A meta-analysis recently reported an absolute survival benefit of more than 16%. However, this study has been criticized, and subsequent meta-analyses have indicated a modest survival benefit for lumpectomy, but not for mastectomy if radiotherapy and/or chemotherapy was also administered. It is possible that, even in the absence of an effective systemic treatment, certain subgroups of high-risk breast cancer might be cured and thereby provide a survival benefit over the ensuing 10-years.

Anonymous Patient Answer

What is breast cancer?

Breast cancer is a cancer in an older population (over 50 years), and most common types are early stage cancer, including ER+ cancers, node-positive disease and luminal A disease. There is a strong correlation between age and breast cancer, which is caused by environmental and physiological factors. Although the exact causes in an ageing population are not know, early research confirms that age is the single main risk factor for cancer: if you live past 50, you're at greater risk than if you were in your 20s.

Anonymous Patient Answer

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

The most common cause of cancer deaths in the United States in both sexes is breast cancer, and 1 out of 4 of the estimated 2.6 million breast cancer cases occur in women aged 80 years and above. Nearly one in twenty women diagnosed with breast cancer dies of the disease before the age of 80.\n\n- Centers for Disease Control and Prevention. National Center for Health Statistics"

Anonymous Patient Answer

What are common treatments for breast cancer?

The treatments used are similar to the management of breast cancer in the general population of women between the ages of 15 and 35 years in Australia.

Anonymous Patient Answer

What are the signs of breast cancer?

A positive family history is an important risk factor for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The presence of red to purple discoloration of the nipples, pain when raising the arms above the head, itching and swelling of the breast(s) are common early signs of breast cancer. A lump near the nipple is an important symptom for breast cancer.

Anonymous Patient Answer

What causes breast cancer?

Many predisposing factors increase the risk of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), but many of these factors are also correlated to each other or with other cancers and thus are not direct causes. Genetic factors, environmental factors such as radiation exposure, or a combination of both are considered the most likely causes.\n

Anonymous Patient Answer

What is the latest research for breast cancer?

This issue is timely, because there is increasing awareness among the scientific community of the benefits of mammography. It is an inexpensive test that can save many lives. The use of mammogram screening by women in the general population, while also limiting the number and impact of breast cancer cases in women without symptoms, is now a recommended practice. There is no 'right time' to start mammograms, and women can start as they are comfortable. However, as we get more information on the benefits of mammograms, it only makes sense to update the public on this information as our population becomes more aware of the benefits and less aware of the risks that mammograms pose.

Anonymous Patient Answer

Is sv-br-1-gm safe for people?

The Sv-br-1-gm is safe for people when carried out at specialist breast health professionals. People are able to cope with the small sore and the gel does not cause any irritation. The only people who would not want it are those who feel that they do not need a topical approach like an intra-muscular injection. There are few concerns about its use for self treatment of breast health, although there is a small risk of contamination with viruses as a number of new and old SVVs can live for several days on human skin.

Anonymous Patient Answer

Who should consider clinical trials for breast cancer?

Clinical trials are highly regarded by patients with breast cancer who participate in decision making. Physicians are not clear about how they should feel. Younger patients are more likely to be satisfied with the results of a trial. Trial participation correlates with satisfaction with care. Patients should be encouraged who are informed about how to decide about clinical trials before being asked to participate.

Anonymous Patient Answer

What is sv-br-1-gm?

The clinical relevance of sv-dr-gm-br is supported. Clinical trials are needed to determine the optimal application as well as to define the usefulness of sv-dr-gm-br-dr versus sv-dr-gm-br-br.

Anonymous Patient Answer

What are the common side effects of sv-br-1-gm?

Most patients reported common side effects, such as fatigue, insomnia, headache, anxiety, and loss of appetite; however, only a few patients suffered from serious side effects, including skin photosensitivity, liver and lung dysfunction, pneumonitis and other pneumonia, and hyperglycaemia. Because the common side effects were similar to those found in previous clinical trials, the use of sv-br-1-gm for the treatment of breast carcinoma seems relatively safe.

Anonymous Patient Answer

How serious can breast cancer be?

The seriousness of breast cancer is variable and requires a high level of suspicion. Once diagnosed, aggressive and comprehensive management improves survival by a remarkable amount.

Anonymous Patient Answer
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