Abemaciclib for Breast Cancer

1
Effectiveness
1
Safety
University of Colorado, Aurora, CO
+2 More
Abemaciclib - Drug
Eligibility
18+
All Sexes
Eligible conditions
Breast Cancer

Study Summary

Phase Ib/II Trial of Abemaciclib and Elacestrant in Patients With Brain Metastasis Due to HR+/Her2- Breast Cancer

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Eligible Conditions

  • Breast Cancer
  • Brain Cancer
  • Breast Neoplasms
  • Brain Neoplasms

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Abemaciclib will improve 2 primary outcomes and 3 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of 1.5 years.

1.5 years
The number of patients in Phase 1b part of the study with any adverse events (AE).
2.5 years
Evaluate duration of tumor response rates of treatment with abemaciclib and elacestrant combination.
Evaluate tumor response rates of treatment with abemaciclib and elacestrant combination.
The percentage of patients to complete the study.
Year 5
Assess the efficacy of the drug combination abemaciclib and elacestrant.

Trial Safety

Safety Estimate

1 of 3

Trial Design

2 Treatment Groups

Control
Abemaciclib/Elacestrant

This trial requires 44 total participants across 2 different treatment groups

This trial involves 2 different treatments. Abemaciclib 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 & 2 and have already been tested with other people.

Abemaciclib/ElacestrantAbemaciclib and Elacestrant combination
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Elacestrant
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2.5 years
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 2.5 years for reporting.

Closest Location

University of Colorado - Aurora, CO

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:
Post-menopausal women with histologically or cytologically diagnosed metastatic HR+/Her2- breast cancer defined as positive for estrogen receptor or progesterone receptor (more than 1% staining by immunohistochemistry, as defined in 2010 ASCO recommendations, Hammond 2010) and negative for HER2 amplification (immunohistochemistry result of 0-1+, or a negative in situ hybridization).
Documented surgical bilateral oophorectomy
Age > 59 years with amenorrhea for > 1 year since last menses
Age < 60 years with amenorrhea for > 1 year since last menses and serum estradiol and FSH in post-menopausal laboratory range.
Patients must have measurable brain metastasis (patients with leptomeningeal disease and measurable parenchymal disease are permitted) with documented intracranial disease progression. One measurable lesion >10mm, or previously irradiated lesion with increase in size by at least 5mm as defined by RANO-BM criteria and revised RECIST criteria (version 1.1, Appendix C). Patients with prior whole brain radiotherapy are permitted.
Prior treatment with up to two lines of systemic chemotherapy for metastatic disease and two weeks from any previous anticancer therapy including biologics and recovered from expected toxicity; at least 4 weeks from major surgery and recovered; at least 3 weeks from radiation affecting more than 25% of bone marrow and recovered; and 2 weeks from other palliative radiation and recovered.
ECOG performance status ≤ 2 (see Appendix B).
Patients who received chemotherapy must have recovered (Common Terminology Criteria for Adverse Events [CTCAE] Grade ≤1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to randomization. A washout period of at least 14 days is required between last chemotherapy dose and randomization (provided the patient did not receive radiotherapy
Patients who received adjuvant radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and randomization.
The patient has adequate organ function for all of the following criteria, as defined in Table 1 below.

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?

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If breast cancer can be cured completely, the chances of cure will be higher because of early diagnosis, treatment and timely follow-up, then the treatment outcome will be better. Although the odds of complete cure may not be high, they can be increased if the breast cancer patient is detected for early detection, is tested and treated appropriately promptly.

Unverified Answer

What are the signs of breast cancer?

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Symptoms of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include a lump, nipple tenderness, a lump or abnormally shaped lump, the feeling that something is stuck or in the breasts, nipple irritation, breast pain or swelling, an unusually rapid or sudden onset of breast pain or bleeding. Most of these signs are not specific to breast cancer, but are common symptoms of other conditions common in women.

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What is breast cancer?

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Breast cancer is a cancer that forms in the cells responsible for the formation of the breast. It begins within the walls of the breasts before invading them. Symptoms are rarely, if ever, found in early breast cancer. A lump in the breast is very often found on the first inspection; it is often more noticeable and may also be accompanied by a nipple that is inverted. A sore or scratch sensation can occasionally be felt. The general sensation might change or feel itchy or itchy might come and go, or a lump can persist for a duration. Older women in the 60s or 70s, or men in their 30s, have a greater chance of being diagnosed with late-stage breast cancer.

Unverified Answer

What are common treatments for breast cancer?

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Treatment for breast cancer is often personalized and tailored to the specific staging of the disease. It has been estimated that 75% of all patients will receive surgery alone. The remainder will be treated with adjuvant therapies. The most common adjuvant therapies are chemotherapy (51%), monoclonal antibodies (25%), hormonal therapies (20%) and radiotherapy (7%), with combination therapy and neoadjuvant therapies being less common but growing in popularity. Survival times are much shorter for postmenopausal women as compared to premenopausal women.

Unverified Answer

What causes breast cancer?

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Although women of all races, socioeconomic groups, and ethnic backgrounds are at risk, certain socioeconomic and geographic factors intensify the risk. A common risk factor for both breast and prostate cancer development seems to be cigarette smoking.

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

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About 1.5 million women in the United States are diagnosed with breast cancer each year. This is about one third of the American women who have a primary breast cancer. The women with breast cancer receive nearly one-third fewer life years and half the total lifetime health care expenses.

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Have there been other clinical trials involving abemaciclib?

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There is little evidence supporting routine use of PIK3CA inhibitors across both first and second lines therapy of metastatic triple negative breast cancer. Clinical trials should continue to involve well-defined and well-defined chemotherapy regimens.

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What is the survival rate for breast cancer?

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Almost all patients present and are treated in a tertiary institution. They present with locally advanced disease and are treated in a specialist department of gynaecology/surgery. The median follow-up time after diagnosis is 6 months (range: 1.6-11.8 months). The overall percentage of patients who are free of cancer disease at 1 year is 74.8% (range: 60.6-86.1%). The median time to tumour recurrence is 4 months (range: 1.9-6.8 months). The median time to death is 8.6 months (range: 3.8-12.7 months).

Unverified Answer

Have there been any new discoveries for treating breast cancer?

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New drugs and therapies are slowly being introduced and reviewed to hopefully change the fate of women with primary breast cancer. The recent history of therapies and research is very rewarding but will not be ready in the present or the future. A new approach should be started and we need to realize we have a responsibility to help the women who already have had to suffer so much. This includes finding a way to find answers to the mysteries of breast cancer.

Unverified Answer

How does abemaciclib work?

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PIK3CA mutated breast cancer patients with abemaciclib are likely to have a higher objective response rate with abemaciclib treatment. Patients with BRCA1/2 mutation or HER2 amplification may benefit from this therapy. ClinicalTrials.gov identification number: NCT02254891.

Unverified Answer

Is abemaciclib safe for people?

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In a retrospective analysis of 10 patients with metastatic breast cancer, abemaciclib was associated with a low rate of grade ≥2 neutropenia and mild skin reactions. The authors concluded that abemaciclib is safe for people. Clinicaltrials.gov ID: NCT02660232.

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What are the common side effects of abemaciclib?

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The majority of the Abemaciclib adverse events reported by patients were considered moderate or mild in severity. The most common abemaciclib-related adverse events were diarrhea and fatigue, both of which occurred in more than 5% of patients; nausea; headache, which occurred in more than 10% of patients; and hypotension, which occurred in more than 5% of patients. Other commonly reported adverse events included rash, dizziness, and nausea. Other uncommonly reported adverse events included blurred vision, fatigue, nausea, rash, and constipation.

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