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New treatment option for Breast Cancer
Official title ABemacicliB or Abemaciclib and HydroxYchloroquine to Target Minimal Residual Disease in Breast Cancer
ClinicalTrials.gov ID: NCT04523857
What this study is testing
What is Abemaciclib?
Abemaciclib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as Verzenio.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase II randomized, controlled, open label breast cancer clinical trial. 66 patients will be enrolled.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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: (i) Lymph node...
- Patients must have completed all primary therapy (definitive surgery, (neo)adjuvant chemotherapy adjuvant radiation and/or Her2-directed therapy) for...
- Bone marrow aspirate obtained via research trial UPCC 28115 after completion of therapy (except endocrine therapy) demonstrates detectable DTCs (via...
- No evidence of recurrent local or distant breast cancer by physical examination, blood tests (CBC, LFTs, Alk Phos), or imaging. Assessment for overt...
You likely can't join if
- 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...
- Prior treatment with abemaciclib is not allowed. (Patients may have received prior CDK4/6 inhibitor therapy with an agent other than abemaciclib...
- 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...
- Patients with hormone-receptor positive breast cancer may not be receiving tamoxifen due to drug-drug interactions with hydroxychloroquine
See the full eligibility 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: (i) Lymph node involvement a. Pathologically-confirmed positive axillary lymph nodes...
- 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...
- 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...
- 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 =/\ 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...
- Prior treatment with abemaciclib is not allowed. (Patients may have received prior CDK4/6 inhibitor therapy with an agent other than abemaciclib. Patients must have discontinued CDK4/6 inhibitor at least 6 months prior...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.