Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Rare Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Kennedy Disease

All Drugs and Chemicals

Antineoplastic Agents

Androgens

Bicalutamide

Androgen Antagonists

Hormones

Hormone Antagonists

Participants receive Abemaciclib 150 mg tablet orally twice daily and Bicalutamide 150 mg orally once daily until disease progression or unacceptable toxicity.

Abemaciclib

Patrick Neven, MD, PhD

Kristien Borremans, MD

Sevilay Altintas, MD, PhD

Kevin Punie, MD

Christel Fontaine, MD

Hannelore Denys, MD, PhD

Annelies Requilé, MD

This study has as goal to evaluate the use of abemaciclib and bicalutamide in androgen receptor positive metastatic triple negative breast cancer.

This study is a phase II single arm clinical trial. Phase II clinical trials test the safety and effectiveness of an intervention to learn whether the intervention works in treating a specific disease.

In this study, the investigators will include patients with locally advanced unresectable or metastatic androgen receptor positive triple negative breast cancer. The participants need to be progressive after at least 1 prior cytostatic regimen in advanced setting.

The participants will be treated with bicalutamide and abemaciclib. Bicalutamide works against the androgen receptor and abemaciclib stops the cell cycle.

The investigators will look into if this combination can help patients with androgen receptor positive triple negative breast cancer. The investigators will also look into if this is a safe combination.

Bicalutamide and Abemaciclib in Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

A Multicenter Single Arm Phase II Study With Bicalutamide in Combination With Abemaciclib in 4 Cohorts of Locoregionally Advanced Inoperable or Metastatic Androgen Receptor-positive Triple-negative Breast Cancer

Disease control rate at week 16 in all patients (cohorts A, B, C and D combined) treated at the selected dose level. DCR is defined as the proportion of patients that present with stable disease, partial response or complete response per RECIST 1.1 at 16 weeks after treatment initiation.

Based on clinically relevant changes from baseline for vital signs and laboratory findings. CTCAE v5.0 uses a range of grades from 1 to 5: grade 1 = mild; grade 2 = moderate; grade 3 = severe; grade 4 = life-threatening; grade 5 = death

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires Core-30 item (QLQ-C30) is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The possible scores for question 1 to 28 are: 1 = not at all; 2 = a little; 3 = quite a bit; 4 = very much. A lower score means a worse outcome.

The possible scores for question 29 and 30 are between 1 and 7 with 1 = very poor and 7 = excellent. A higher score means a better outcome.

Disease control rate (DCR) at 16 weeks for treatment with abemaciclib in combination with bicalutamide in the subgroup with positive AR IHC in ≥10% of cells. DCR is defined as the proportion of patients that present with stable disease, partial response or complete response per RECIST 1.1 at 16 weeks after treatment initiation.

Disease control rate (DCR) at 16 weeks for treatment with abemaciclib in combination with bicalutamide in subgroups A, B, C and D separate. DCR is defined as the proportion of patients that present with stable disease, partial response or complete response per RECIST 1.1 at 16 weeks after treatment initiation.

Disease control rate (DCR) at 24 weeks for treatment with abemaciclib in combination with bicalutamide in all patients, in the 4 cohorts separate and in the subgroups with IHC for AR ≥10%. DCR is defined as the proportion of patients that present with stable disease, partial response or complete response per RECIST 1.1 at 24 weeks after treatment initiation.

Overall response rate (ORR) at 16 weeks in all patients with measurable disease, in the 4 cohorts separate and in the subgroups with IHC for AR ≥10%. ORR is defined as the proportion of patients that present with partial response or complete response per RECIST 1.1 at 16 weeks after treatment initiation.

Duration of response (DOR) in all patients with measurable disease and partial or complete response, in the 4 cohorts separate and in the subgroups with IHC for AR ≥10%. DOR is defined as the time from response until disease progression or death in patients who achieve complete or partial response.

Progression free survival (PFS) in all patients, in the 4 cohorts separate and in the subgroups with IHC for AR ≥10%. PFS is defined as the time from start of treatment until disease progression/relapse or death from any cause. If the specific event (disease progression/relapse, death, whatever comes first) does not occur, PFS will be censored at the date of last tumor assessment. In case no tumor assessment is available, patients will conservatively be censored at the date of first bicalutamide + abemaciclib dose.

Overall survival (OS) in all patients, in the 4 cohorts separate and in the subgroups with IHC for AR ≥10%. OS is defined as the time from start of treatment until death from any cause. Patients who are still alive at the time of OS analysis will be censored at the last date they were known to be alive.

Spots Global Cancer Trial Database for receptors, androgen