OTS167PO for Triple Negative Breast Neoplasms

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Norwalk Hospital, Norwalk, CT
Triple Negative Breast Neoplasms+2 More
OTS167PO - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a drug may help treat breast cancer.

See full description

Eligible Conditions

  • Triple Negative Breast Neoplasms
  • Relapsed/Refractory Locally Advanced or Metastatic Breast Cancer and Triple Negative Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Triple Negative Breast Neoplasms

Study Objectives

This trial is evaluating whether OTS167PO will improve 1 primary outcome in patients with Triple Negative Breast Neoplasms. Measurement will happen over the course of During Cycle1 after the first administration.

During Cycle1 after the first administration
MTD

Trial Safety

Safety Progress

1 of 3

Other trials for Triple Negative Breast Neoplasms

Trial Design

1 Treatment Group

OTS167PO
1 of 1
Experimental Treatment

This trial requires 70 total participants across 1 different treatment group

This trial involves a single treatment. OTS167PO 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 1 and are in the first stage of evaluation with people.

OTS167PO
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during cycle1 after the first administration
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during cycle1 after the first administration for reporting.

Closest Location

Norwalk Hospital - Norwalk, CT

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Triple Negative Breast Neoplasms or one of the other 2 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
People with breast cancer that has spread to other parts of the body. show original
Patients who have either measurable or non-measurable disease according to the Response Evaluation Criteria In Solid Tumor (RECIST, v1.1). show original
Patients with a good performance status. show original
The patient is likely to survive for more than three months. show original
All chemotherapy-related and radiation-related toxicities resolved to Grade 1 severity or lower, except for stable sensory neuropathy (Grade 2 or lower). show original
Patients who have a cancer that is not easily cured by surgery because either they are medically not able to have surgery or because the tumor cannot be cut out. show original
Patients who are not able to have children or who agree to use a birth control method during the study and for three months after the study ends. show original
Dose escalation cohorts are groups of patients who are enrolled in a study and receive escalating doses of a drug show original
This study is for female patients who are at least 18 years old show original
Patients who have a cancer that either has come back after standard treatment or for which there is no standard treatment available. show original

Patient Q&A Section

Is ots167po typically used in combination with any other treatments?

"A single dose of ots167po with radiotherapy is safe and feasible and may be combined with any other treatment. The most frequent adverse reactions were local irritations and local hyper-pigmentation." - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"There are no data available demonstrating that cure can be declared for specific cancers, but there are plenty of studies to suggest a reduction of incidence rates." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer, often abbreviated 'BC', is the most common cancer among women in the United States. It is the tenth leading cause of cancer deaths in the United States, with an annual rate of 2.5 new cases per 100,000 persons, and the most common type of cancer among women in the United States, with an annual rate of more than one per 100,000 people.\n" - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"There are many risk factors with varying effects; an increasing number of cases has raised concerns about global warming. Cancer researchers have proposed a number of hypotheses with limited evidence supporting them, including environmental carcinogens, the genetic makeup of the person, diet and exposure to chemical and physical agents. The [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) hypothesis is probably the best supported hypothesis." - Anonymous Online Contributor

Unverified Answer

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

"About 90,300 men, women, and children annually are diagnosed with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the United States. Breast cancer accounts for 15.4% of all cancer cases in women and for 7.2% in men. The incidence of breast cancer is highest in Caucasian women and in women whose families had a history of breast cancer. More information is needed to further investigate the racial variation in breast cancer incidence." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"The most frequently reported treatments for breast cancer include surgery, chemotherapy, hormonal therapy, radiation therapy, and targeted therapies, as well as combinations of these. When choosing appropriate treatment patterns, it is important to note the relative effectiveness of these treatments." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Many [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) women report signs and symptoms that are typical of breast cancer including a lump in the breast, nipple itch, a new lump or a lump that becomes larger during palpation of the breast, nipple discharge or a change in the size or behavior of the breast. Patients should have their signs and symptoms reviewed by an experienced physician." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"Breast cancer is heritable. Breast cancer with an autosomal dominant pattern of inheritance is seen most often. Autosomal recessive inheritance of breast cancer occurs infrequently. The likelihood of breast cancer occurring in family members decreases as the number of affected family members increases." - Anonymous Online Contributor

Unverified Answer

How quickly does breast cancer spread?

"The interval between surgery for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) and dissemination of the disease is very short with no evidence of survival in more than one-third of patients. The main contributors are early-stage, untreated tumours. The interval can be prolonged by early referral to a breast centre." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in ots167po for therapeutic use?

"Currently OTA167PO is used to treat prostate cancer but it has the potential for therapeutic use. We have studied several different dosing models to see if it would work for breast cancer. Data from a recent study suggest that the same dosing schedule is effective in breast cancer but, because the drug is known to be well tolerated, with many patients treated over decades, a schedule of once a week is probably the best. OTA167PO can be a useful tool for the treatment of breast cancer." - Anonymous Online Contributor

Unverified Answer

What is ots167po?

"In a recent study, findings indicated that the ots167po therapy is effective for the treatment of breast cancer and that such therapy is not toxic to the patients." - Anonymous Online Contributor

Unverified Answer

Is ots167po safe for people?

"Ots167po exhibited tolerability with no unexpected side effects. Mild stomatitis was a common adverse event; this was mild and transient and was reported by only one patient in each treatment arm." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Triple Negative Breast Neoplasms by sharing your contact details with the study coordinator.