Printed from Voxsanity (voxsanity.com.au) — NCT04841148 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.
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Phase 2 Breast Cancer Trial, Recruiting
NCT04841148
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who may be able to join
- After completing all main breast cancer treatment, a bone marrow sample (tested at the University of Pennsylvania) shows small numbers of cancer-related cells still detectable.
- A person has been diagnosed with stage II or III breast cancer that tested positive for estrogen receptors (ER+) and negative for HER2, with no signs of the cancer coming back. People with cancer in both breasts may still be eligible if both cancers fit these criteria.
- The breast cancer tumour tested positive for estrogen receptors (ER+) and negative for HER2. Tumours that are estrogen receptor-negative but progesterone receptor-positive are not eligible.
- All main treatments (surgery, chemotherapy, and radiation) have been completed, except for ongoing hormone (endocrine) therapy. Any side effects from previous treatment must have mostly resolved before joining.
- A person may have previously received a type of cancer drug called a CDK4/6 inhibitor, as long as it was not Palbociclib and was stopped at least 6 months before screening.
- A person must currently be receiving adjuvant hormone (endocrine) therapy, and must have started that therapy between 2 and 7 years before enrolling. People taking tamoxifen may need to switch to a different hormone therapy (an aromatase inhibitor) at least 21 days before starting study treatment if assigned to certain trial arms (confirm with trial site). Women who have not yet gone through menopause and are using ovarian suppression therapy are eligible.
- People already taking bone-strengthening medications (such as bisphosphonates or RANK-ligand inhibitors) may continue them, but these medications cannot be started for the first time during the trial.
- A person is not currently enrolled in any other clinical trial involving an experimental treatment.
- Adults aged 18 years or older, both men and women.
- A person has no medical reasons that would prevent them from safely taking the study medications, and no serious uncontrolled health conditions.
- A person has adequate bone marrow, liver, and kidney function (confirm specific thresholds with trial site).
- A person is able to speak and understand English.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People who have had a previous separate invasive breast cancer diagnosis. People with a prior non-invasive breast condition called DCIS may still be eligible if it was diagnosed more than 5 years before joining. People with a history of other cancers (not breast cancer) may be eligible if they have been cancer-free for at least 5 years.
- People who are regularly taking high doses of steroid medications (such as prednisone or similar drugs) or other immune-suppressing medications. Steroid creams or inhalers are generally acceptable.
- People whose heart electrical activity test (ECG) shows a reading called QTc greater than 480 ms, indicating a potential heart rhythm concern.
- People with certain serious or uncontrolled health conditions, including:
- A chronic autoimmune disease
- Significant uncontrolled heart rhythm problems (note: controlled atrial fibrillation is generally acceptable)
- A heart attack, unstable angina, or certain heart procedures within the 6 months before enrolling
- Moderate to severe heart failure (Class II or above as defined by a standard medical scale)
- A history of lung inflammation (pneumonitis) or seriously reduced lung function, or blood oxygen levels of 88% or below while at rest
- Uncontrolled diabetes
- Active or uncontrolled serious infections
- Serious liver disease such as cirrhosis or chronic hepatitis
- People living with HIV who are currently on combination HIV treatment, due to potential interactions with the study drug Palbociclib
- Conditions affecting the digestive system that could interfere with how the body absorbs one of the study drugs (hydroxychloroquine), such as severe nausea, vomiting, diarrhoea, or malabsorption conditions
- Active uncontrolled bleeding conditions, or people currently taking blood-thinning (anticoagulant) medications
- A history of eye conditions affecting the retina (the back of the eye)
- People who are pregnant or breastfeeding, or people of reproductive age who are not using effective contraception.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Contact this trial
Principal Investigator: Angela DeMichele, MD, University of Pennsylvania
Phone: 215-615-2367
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
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Trial details
Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
1 June 2021
Est. completion
1 July 2027
Where this trial is recruiting
🇺🇸 United States
Primary endpoints
Determine the efficacy of HCQ or Avelumab, alone or in combination with Palbociclib, in eradicating DTCs
Can't join this trial?
Data last synced from ClinicalTrials.gov: 30 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.
Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.