Afuresertib for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Mississippi Medical Center, Jackson, MS
Breast Cancer+1 More
Afuresertib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Study Evaluating Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients w/ Locally Advanced or Metastatic HR+/HER2- Breast Cancer

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Eligible Conditions

  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Afuresertib will improve 1 primary outcome and 7 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of Assessed on Day 1 and Day 15 of Cycle 1 (each cycle is 28 days).

Year 1
Progression Free Survival (PFS) based on RECIST 1.1
Day 28
Pharmacokinetics- Area Under the Curve (AUC)
Pharmacokinetics- Time to Maximum Concentration (T-Max)
Year 1
Best Overall Response (BOR) based on RECIST 1.1
Disease Control Rate (DCR) based on RECIST 1.1
Duration of Response (DOR) based on RECIST 1.1
Year 1
Overall Response Rate (ORR) based on RECIST 1.1
Month 12
Frequency and severity of Adverse Events (AEs)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Afuresertib and Fulvestrant
1 of 2
Afuresertib and Fulvestrant Safety Run In
1 of 2
Experimental Treatment

This trial requires 20 total participants across 2 different treatment groups

This trial involves 2 different treatments. Afuresertib is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Afuresertib and Fulvestrant
Drug
Combination regimens are: afuresertib 125 mg QD (once daily) or 125 mg Day1-21 Q4W + fulvestrant 500 mg or 250 mg Intra Muscular (IM) on Day 1, 15 of Cycle 1, and on Day 1 of the subsequent 28-day cycles.
Afuresertib and Fulvestrant Safety Run In
Drug
Safety run-in Cycle 1 (a cycle is 28 days) will be performed in the first 6 patients of the phase Ib. Combination regimens during the safety run-in period are: afuresertib 125 mg QD (once daily) or 125 mg Day1-21 Q4W + fulvestrant 500 mg or 250 mg Intra Muscular (IM) on Day 1, 15 of Cycle 1, and on Day 1 of the subsequent 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion for an average of 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion for an average of 12 months for reporting.

Closest Location

University of Mississippi Medical Center - Jackson, MS

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Breast Cancer or the other condition 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:
Female or male patients must be ≥ 18 years of age on the day of signing the informed consent and be able to provide written informed consent for the study.
Patients with histologically or cytologically confirmed HR+/HER2- BC characterized by the absence of HER2 expression and the presence of ER and/or PR expression.
Female patients must be post-menopausal. Female patients who are pre- or peri-menopausal must have ovarian suppression therapy with LHRH while on study.
Prior bilateral oophorectomy
Age ≥ 60 y
Age < 60 y and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and estradiol in the postmenopausal range
If taking tamoxifen or toremifene, and age < 60 y, then FSH and plasma estradiol level in postmenopausal ranges
Before randomization, patients who have undergone anti-cancer treatment must have a washout period of 4 weeks or 5 half-lives, whichever comes earlier.
Relapsed locally advanced (LABC) or metastatic (mBC) disease;
i. Endocrine therapies including AIs and/or SERMs (1 or 2 lines); OR ii. A CDK4/6 inhibitor in combination with endocrine therapy (1 line), with or without additional line of endocrine therapy (1 line); OR Afuresertib Plus Fulvestrant Versus Placebo Plus Fulvestrant As Treatment for HR+/HER2- Breast Cancer Protocol Number: LAE205INT3101 Document Version: 0.9 NCT Identifier Number: March 15, 2021 44 iii. A chemotherapy (monotherapy or combination therapy, 1 line only), with or without additional line of endocrine therapy.

Patient Q&A Section

What are the signs of breast cancer?

"The presenting complaint of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is usually an expanding, painless lump. It may also occur with or without nipple discharge or nipple redness. There are signs of breast cancer by physical examination of the breast. These include a nipple that changes shape and size with posture, and a palpable lump. A breast with a swollen gland or a lump in the armpit may also be a sign of breast cancer.\n" - Anonymous Online Contributor

Unverified Answer

Can breast cancer be cured?

"Although there are no absolute facts, women who had [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) do not routinely develop other cancers later in the remainder of their lives. Furthermore, women who have survived both breast and colon cancers typically have a significantly lower risk of cancer again than women who endured only one of the two diseases." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"Breast cancer incidence has increased over the last decade. This may have been due to increase in obesity, which is linked with a higher risk of breast cancer, and is also associated with increased estrogen. This may have led to increased estrogen exposure in women which has caused increased breast cancer risk. This may be why breast cancer occurs most often in women who were young and/or obese during their lifetime. These risk factors may also increase an individual's susceptibility to cancer, and lead to a higher rate of breast cancer in men and women. The increase in breast cancer susceptibility could be further explained by the increase in estrogen sensitivity resulting from obesity. This change in estrogen sensitivity may have caused increased breast cancer risk among women." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Common treatments for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include antiestrogen medication, aromatase inhibitors (AI), letrozole, tamoxifen, or ganitumab, chemotherapy, and targeted therapies. A multimodal approach, which combines surgical removal of the breast with various forms of chemotherapy and/or targeted therapy, has more favorable results during treatment. When breast cancer has metastasized, the prognosis is poor." - Anonymous Online Contributor

Unverified Answer

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

"Around 200,000 women will die of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) in the United States each year. As in Denmark, this makes breast cancer the leading cause of cancer-related death of women in the United States." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a cancer that forms in the breast tissues and causes uncontrolled cell growth or spread to other areas of the body. It is the most common type of cancer in women. It occurs when cells start to multiply outnumbering their normal counterparts, can grow in the wrong areas, or in women with a family history of the cancer can progress to the next stage quicker than in other women. Women who receive treatment early can have a better outcome in preventing the recurrence of their cancer. The risk of breast cancer increases with increasing age." - Anonymous Online Contributor

Unverified Answer

Is afuresertib safe for people?

"There was no significant impact of afuresertib on renal or haematological systems, which supports the safety of afuresertib for the treatment of people with metastatic breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"The majority of literature on [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can be grouped into four main areas: (1) epidemiology, (2) the prevention of breast cancer (BC), (3) the effectiveness of screening programs, and (4) the treatment of localized cancer." - Anonymous Online Contributor

Unverified Answer

How does afuresertib work?

"In summary, these findings demonstrate that the combination of afuresertib plus docetaxel or carboplatin is well tolerated and exerts a synergistic effect blocking Caspase-9 and -3 in vitro with preferential interference on PI3K/RAF/AKT signaling, in agreement with in vivo molecular data. The combination is able to exert a strong anti-mitotic effect in a wide range of cancer cell lines and can achieve antitumor activity in xenografts including resistant tumors. Results from a recent clinical trial strongly support further clinical development of afuresertib plus chemotherapic-based treatment in HER2-negative and TP53-defective breast cancer." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets breast cancer?

"The average age for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) is around 48 and this is more common in women's lives than men's lives; however, it can occur at any age. Breast cancers are not more common as women get older. For ages 25-40, there is one in five diagnosed cases of breast cancer. In some circumstances, like pregnancy (when estrogen is higher) or breastfeeding (when estrogen level is higher), women have a significantly higher risk of getting a breast cancer. Most cases of breast cancer happen outside of the age of 50 but when they do occur, it tends to be sooner rather than later in life." - Anonymous Online Contributor

Unverified Answer

What are the chances of developing breast cancer?

"Even though women can diminish their risk, it is still not negligible as only every seventh woman will get breast cancer during her life. The main reason is that genetics play a greater role in breast cancer than is commonly believed. Genetic predisposition and familial disease patterns are more important than external factors like diet, UV irradiation, hormone use, environmental exposures, and infection with pathogenic viruses in breast cancer genesis. To prevent and treat breast cancer, we have to not only focus on external factors, but also on hereditary factors." - 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.
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