RECRUITING

ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled. The drugs being studied are hydroxychloroquine (Plaquenil) and abemaciclib (also Verzenio). This research study is testing whether using these drugs to target the disseminated tumor cells in bone marrow can reduce their number or eliminate them. Both hydroxychloroquine and abemaciclib are pills that will be taken twice daily. Both are approved by the FDA

Official Title

A Phase II Pilot Trial of ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer Patients ("ABBY")

Quick Facts

Study Start:2021-11-01

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04523857

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of entry into the companion DTC screening protocol UPCC 28115 * Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines, meting at least one of the following: * Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry. Prior treatment-related toxicity must be resolved or improving to Grade 1 with the exception of alopecia, Grade 2 endocrine disorders (e.g. adrenal insufficiency or thyroid disorders from prior immunotherapy) controlled on stable replacement therapy for \> 1 year, and up to Grade 3 peripheral neuropathy, prior to study enrollment. Concurrent receipt of adjuvant endocrine and bone modifying agents is allowed per standard of care guidelines. Tamoxifen is not allowed due to drug-drug interactions with HCQ. * Bone marrow aspirate obtained via research trial UPCC 28115 after completion of therapy (except endocrine therapy) demonstrates detectable DTCs (via IHC) * No evidence of recurrent local or distant breast cancer by physical examination, blood tests (CBC, LFTs, Alk Phos), or imaging. Assessment for overt metastatic disease by radiologic testing per institutional guidelines (CT Chest, Abdomen and Pelvis, bone scan, MRI and/or PET/CT) will only be done in patients with DTCs detected on bone marrow aspirate who are being screened for this trial. * Age \>/= 18 years * ECOG performance status =/\< 2 * Ability to swallow oral medications * No contraindications to the study medications or uncontrolled medical illness. * Adequate bone marrow function as shown by: ANC \>/= 1.5 x 10\^9/L, Platelets \>/= 100 x 10\^9/L, Hb \>9 g/dL * Adequate liver function as shown by: Serum bilirubin \</= 1.5 x ULN, ALT and AST \</= 3.0 x ULN, and INR \</=1.5 * Adequate renal function: serum creatinine \</= 1.5 x ULN * Adequate muscle function: creatinine phosphokinase (CPK) \</= 2.5 x ULN * Anticoagulation is allowed if target INR =/\< 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for \>2 weeks at time of randomization * Ability to provide informed consent * Concurrent enrollment on another investigational therapy * Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization (or treatment assignment), or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study. * Prior treatment with a CDK 4/6 inhibitor * Known hypersensitivity to hydroxychloroquine or any of its derivatives * Prior hydroxychloroquine exposure for a duration of \> 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and/or Her2-directed therapy) for the index malignancy. * Patients with hormone-receptor positive breast cancer may not be receiving tamoxifen due to drug-drug interactions with hydroxychloroquine * Patients who have initiated bone modifying agents within 3 months prior to the start of study treatment * Patients who have had major surgery within 14 days prior to randomization (or treatment assignment) * Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study * Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. * Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of Abema	Pregnancy or breastfeeding Severe psychiatric disorders Active substance abuse Unstable medical conditions Inability to comply with study requirements

Inclusion Criteria

Exclusion Criteria

* Histologically-confirmed, primary, invasive breast cancer diagnosed within 5 years of entry into the companion DTC screening protocol UPCC 28115
* Qualifying risk status, at diagnosis utilizing receptor testing by ASCO/CAP guidelines, meting at least one of the following:
* Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for the index malignancy at least 4 weeks prior to study entry. Prior treatment-related toxicity must be resolved or improving to Grade 1 with the exception of alopecia, Grade 2 endocrine disorders (e.g. adrenal insufficiency or thyroid disorders from prior immunotherapy) controlled on stable replacement therapy for \> 1 year, and up to Grade 3 peripheral neuropathy, prior to study enrollment. Concurrent receipt of adjuvant endocrine and bone modifying agents is allowed per standard of care guidelines. Tamoxifen is not allowed due to drug-drug interactions with HCQ.
* Bone marrow aspirate obtained via research trial UPCC 28115 after completion of therapy (except endocrine therapy) demonstrates detectable DTCs (via IHC)
* No evidence of recurrent local or distant breast cancer by physical examination, blood tests (CBC, LFTs, Alk Phos), or imaging. Assessment for overt metastatic disease by radiologic testing per institutional guidelines (CT Chest, Abdomen and Pelvis, bone scan, MRI and/or PET/CT) will only be done in patients with DTCs detected on bone marrow aspirate who are being screened for this trial.
* Age \>/= 18 years
* ECOG performance status =/\< 2
* Ability to swallow oral medications
* No contraindications to the study medications or uncontrolled medical illness.
* Adequate bone marrow function as shown by: ANC \>/= 1.5 x 10\^9/L, Platelets \>/= 100 x 10\^9/L, Hb \>9 g/dL
* Adequate liver function as shown by: Serum bilirubin \</= 1.5 x ULN, ALT and AST \</= 3.0 x ULN, and INR \</=1.5
* Adequate renal function: serum creatinine \</= 1.5 x ULN
* Adequate muscle function: creatinine phosphokinase (CPK) \</= 2.5 x ULN
* Anticoagulation is allowed if target INR =/\< 1.5 on a stable dose of warfarin or on a stable dose of anticoagulant for \>2 weeks at time of randomization
* Ability to provide informed consent
* Concurrent enrollment on another investigational therapy
* Patient has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer, prior to randomization (or treatment assignment), or is currently enrolled in any other type of medical research (for example: medical device) judged by the sponsor not to be scientifically or medically compatible with this study.
* Prior treatment with a CDK 4/6 inhibitor
* Known hypersensitivity to hydroxychloroquine or any of its derivatives
* Prior hydroxychloroquine exposure for a duration of \> 1 month since the completion of the patient's primary therapy (definitive surgery, (neo)adjuvant chemotherapy, adjuvant radiation, and/or Her2-directed therapy) for the index malignancy.
* Patients with hormone-receptor positive breast cancer may not be receiving tamoxifen due to drug-drug interactions with hydroxychloroquine
* Patients who have initiated bone modifying agents within 3 months prior to the start of study treatment
* Patients who have had major surgery within 14 days prior to randomization (or treatment assignment)
* Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study
* Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods.
* Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose of Abema

Pregnancy or breastfeeding
Severe psychiatric disorders
Active substance abuse
Unstable medical conditions
Inability to comply with study requirements

Contacts and Locations

Study Contact

Lauren Bayne, PhD

CONTACT

215-615-2367

breastcancerclinicaltrials@pennmedicine.upenn.edu

Principal Investigator

Amy Clark, MD

PRINCIPAL_INVESTIGATOR

Abramson Cancer Center at Penn Medicine

Study Locations (Sites)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

United States

Collaborators and Investigators

Sponsor: Abramson Cancer Center at Penn Medicine

Amy Clark, MD, PRINCIPAL_INVESTIGATOR, Abramson Cancer Center at Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-01

Study Completion Date2028-12

Study Record Updates

Study Start Date2021-11-01

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Breast Cancer