Abemaciclib for Breast Cancer

Phase-Based Estimates
1
Effectiveness
1
Safety
Seoul National University Hospital, Seoul, Korea, Republic of
Breast Cancer+1 More
Abemaciclib - Drug
Eligibility
18+
Female
Eligible conditions
Breast Cancer

Study Summary

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

See full description

Eligible Conditions

  • Breast Cancer
  • Breast Neoplasms
  • Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Abemaciclib will improve 12 primary outcomes and 5 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of From Baseline until 30 days after the last dose of study drug (up to 6 years).

Day 30
Serum Concentration of Pertuzumab in PH FDC SC Treatment Arms at Specified Timepoints
Serum Concentration of Trastuzumab in PH FDC SC Treatment Arms at Specified Timepoints
Day 28
Blood Concentration of Everolimus at Specified Timepoints
Plasma Concentration of Ribociclib at Specified Timepoints
Day 28
Plasma Concentration of Inavolisib at Specified Timepoints
Plasma Concentration of Ipatasertib at Specified Timepoints
Day 30
Plasma Concentration of Abemaciclib at Specified Timepoints
Plasma Concentration of Palbociclib at Specified Timepoints
Day 30
Plasma Concentration of Giredestrant at Specified Timepoints
Plasma Concentration of Samuraciclib at Specified Timepoints
Year 6
Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Year 6
Clinical Benefit Rate, Defined as the Percentage of Participants with Stable Disease for ≥24 Weeks or with Confirmed Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Disease Control Rate, Defined as the Percentage of Participants with Stable Disease for ≥12 Weeks or a Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Percentage of Participants with Objective Response, Defined as a Complete or Partial Response, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Year 6
Duration of Response, as Determined by the Investigator According to RECIST v1.1
Year 6
Overall Survival
Year 6
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1

Trial Safety

Safety Estimate

1 of 3

Trial Design

11 Treatment Groups

Giredestrant Monotherapy
Cohort 1: Giredestrant + Samuraciclib

This trial requires 415 total participants across 11 different treatment groups

This trial involves 11 different treatments. Abemaciclib is the primary treatment being studied. Participants will be divided into 8 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Cohort 1: Giredestrant + Samuraciclib
Cohort 2: Giredestrant + PH FDC SC + Palbociclib
Cohort 1: Giredestrant + Ribociclib
Cohort 1: Giredestrant + Inavolisib
Cohort 1: Giredestrant + Abemaciclib
Cohort 1: Giredestrant + Ipatasertib
Cohort 1: Giredestrant + Everolimus
Cohort 2: Giredestrant + PH FDC SC + Abemaciclib
Giredestrant Monotherapy
Cohort 1: Giredestrant Monotherapy
Drug
Cohort 2: Giredestrant + PH FDC SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Abemaciclib
FDA approved
Giredestrant
2019
Completed Phase 2
~300
Ipatasertib
Not yet FDA approved
Ribociclib
FDA approved
Palbociclib
FDA approved
Everolimus
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline until disease progression (up to 6 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from baseline until disease progression (up to 6 years) for reporting.

Closest Location

Levine Cancer Institute - Charlotte, NC

Eligibility Criteria

This trial is for female patients 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:
You have a performance status of 0 or 1. show original
You have had breast cancer and have had no recurrence or progression of the disease for at least 2 years. show original
Documented estrogen receptor-positive (ER+) tumor Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
Postmenopausal status for women
Life expectancy ≥3 months
Prior fulvestrant therapy is allowed
Stages 1 and 2: Measurable disease (at least one target lesion) according to RECIST v1.1
You have a complete blood count (CBC) and your hematologic and end-organ functions are normal. show original
You have disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease. show original
You have a tumor that is suitable for evaluation of Ki67, and/or additional biomarkers via central testing. show original

Patient Q&A Section

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

What are the signs of breast cancer?

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Symptoms in [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) may include breast lump, axillary or groin lymphadenopathy, or an irregular mass in the breast or in one of the chest pockets. Breast cancer can also present with nipple discharge and the redness and swollen of the breast. In general, symptoms are more common in women with late-stage disease. Breast cancer can usually be diagnosed clinically based on the presence of the signs above, or through screening. In some cases, a breast lump may be suggestive of breast cancer if it is palpable and does not disappear during a breast self examination. There are several treatments for breast cancer, including surgery, chemotherapy, hormonal therapy or other interventions.

Unverified Answer

Can breast cancer be cured?

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There are reasons to believe that [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) can be cured with optimal tumour resection and adjuvant systemic chemotherapy. However, the possibility remains forever that some breast cancers which are amenable to surgery will recur, and that in some patients breast cancer will have a fatal outcome, either due to cancer cells which have escaped surgical removal or to the effects of adjuvant chemotherapy that kills cancer cells in addition to the tumour. Patients should therefore be encouraged to take decisions with which they are willing to live.

Unverified Answer

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

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Although a minority of the total [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) population, women in the SEP and women not receiving mammography every 3 years constitute a very large fraction of new cancer diagnoses. Breast cancer has a wide burden among the population. It is important that the public be aware of these data to understand cancer prevention.

Unverified Answer

What causes breast cancer?

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The cause of breast cancer is not understood, but it is likely connected to a wide range of environmental factors including lifestyle, environment, family history of breast cancer, and genetics. As environmental risk factors for breast cancer become better defined, it is hoped that our understanding will be improved, and more effective programs can be developed.

Unverified Answer

What is breast cancer?

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Breast cancer, a life-threatening cancer, is a chronic, life-changing illness that impacts an individual's quality of life, can be treated, and in some cases is prevented. The symptoms of breast cancer onset, and the indicators and effects that symptomology produces in women are very diverse and vary from woman to woman. This is especially true for those who are newly diagnosed. Symptoms can develop very quickly or they can mimic other common conditions. This variability in symptoms and the inability to predict when women will develop breast cancer means that women may feel unwell for long periods of time. If a woman is diagnosed with breast cancer it is very important for her and her family to be aware that the symptoms may be different each time.

Unverified Answer

What are common treatments for breast cancer?

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Among the medications used for the treatment of [metastatic breast cancer](https://www.withpower.com/clinical-trials/metastatic-breast-cancer), tamoxifen, letrozole, cyclophosphamide, doxorubicin, trastuzumab and taxanes. Chemotherapeutic medicines used for treatment of breast cancer can be divided into chemotherapy drugs, antiestrogens, monoclonal antibody, and HER-2 antagonists.

Unverified Answer

How quickly does breast cancer spread?

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The vast majority of breast cancer cases, more than 85% in this study, spread within 15 years of diagnosis to other locations in the body, with the most common being to the lungs and the bone\n\n2. Joan Rivers. Joan Rivers was diagnosed with breast cancer in 1995. Two more diagnoses would follow, including a triple-Negative Breast Cancer (TNBC, which is rarely found outside of East Africa and New Zealand). Her fight went on for nearly 20 years until she died, at the age of 60, from what was found to be Non-Hodgkin's lymphoma, another TNBC.

Unverified Answer

How serious can breast cancer be?

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Breast cancer is a serious disease even among those who are very young. The average age at which breast cancer was diagnosed in our population is 47.

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What are the latest developments in abemaciclib for therapeutic use?

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These data suggest that AIs are effective and that they increase the duration of PFS in HER2 positive breast cancer relative to taxane. Furthermore, the combination of AIs and chemotherapy may increase the duration of PFS of HER2-positive breast cancer relative to chemotherapy. Findings from a recent study suggests that abemaciclib is effective in patients with HER2+/neu+ with metastatic breast cancer.

Unverified Answer

What are the common side effects of abemaciclib?

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Abemaciclib has an excellent safety profile with no appreciable changes observed in circulating or urine biomarkers during the studies. The most common side effects of abemaciclib were diarrhoea, dizziness, headache, nausea, abdominal pain, fatigue, weakness, rash, alopecia, skin irritation and vomiting.

Unverified Answer

How does abemaciclib work?

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Clinically, abemaciclib monotherapy induces tumor growth inhibition in HER2+ breast cancers as demonstrated by the fact that treatment does not lead to any new recurrences for patients with HER2+ tumors after 2 to 4 years follow-up.

Unverified Answer

What is the average age someone gets breast cancer?

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Findings from a recent study shows that there was little significant difference in the age of when breast cancer diagnosed for male vs. female patients. A larger retrospective study is needed to determine the average age at diagnosis with regard to male vs. female patients.

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