AzTrials
AzTrials

Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS)Phase 2AIMSSNCT07825454

Pilot Study of Hydroxychloroquine for the Treatment of AIMSS

A Phase 2 study testing Hydroxychloroquine Sulfate (HCQ) in people with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) and Joint Pain, run by Indiana University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hydroxychloroquine Sulfate (HCQ)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
Sep 2026to Dec 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age ≥ 18 years at the time of informed consent
  • Ability to provide written informed consent and HIPAA authorization
  • Diagnosis of DCIS or stage I, II, or III breast cancer
  • Currently receiving adjuvant aromatase inhibitor therapy (anastrozole, letrozole or exemestane) for ≥ 4 weeks prior to enrollment Note: Concurrent use of ovarian suppression is allowed Note: Concurrent use of CDK4/6 inhibitors is not allowed due to cytopenia risk
  • New or worsening self-reported musculoskeletal pain that began or significantly worsened after initiation of AI therapy
  • BPI average pain score of ≥ 4 during screening
Show all 15Show fewer
  • ECOG PS 0-2
  • Adequate organ function:
  • Absolute neutrophil count ≥1,500/µL
  • Hemoglobin ≥11.0 g/dL
  • Platelet count ≥100,000/µL
  • Serum creatinine ≤1.5× upper limit of normal (ULN) or eGFR ≥60 mL/min/1.73m2
  • Total bilirubin ≤1.5× ULN (except in patients with documented Gilbert's disease, who must have a total bilirubin < 3.0 mg/dL)
  • AST and ALT ≤1.5× ULN
  • Must agree to maintain stable doses of any analgesic medications or other AIMSS related therapies during the study period Note: rescue doses of acetaminophen or ibuprofen allowed on a non-daily basis, unless not new

Who cannot join

  • Current or prior use of hydroxychloroquine or chloroquine within 6 months
  • Known hypersensitivity to hydroxychloroquine, chloroquine, or 4-aminoquinoline compounds
  • History of retinopathy or retinal vein occlusion issues Note: While there is an association between retinopathy and HCQ use, this occurs rarely and with long term use with higher cumulative doses that used here. Other clinical trials have not required retinal exam (example: CTO-TBCRC04627, approved by IU IRB)
  • History of congestive heart failure (any NYHA class)
  • QTc prolongation (>450 msec) at screening or history of significant arrhythmias requiring treatment
  • Moderate to severe renal impairment (eGFR <60 mL/min/1.73m2)
Show all 20Show fewer
  • Use of a prohibited concomitant medication (refer to Section 6.3.2) that cannot be discontinued or changed to an alternate therapy
  • Known glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • History of porphyria
  • History of psoriasis
  • History of antiepileptic medications
  • Known history of inflammatory arthritis (example: rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis) or connective tissue disease (example: systemic lupus erythematosus, scleroderma, polymyositis)
  • Recent initiation or dose change (within 4 weeks) of medications for pain management (NSAIDs, duloxetine, gabapentin, pregabalin, opioids) Note: Patients on stable doses for >4 weeks are eligible
  • Patients currently receiving or planned to receive high dose systemic treatment with corticosteroids defined as: cortisone >50mg; hydrocortisone >40mg, prednisone >10mg, methylprednisolone >8mg or dexamethasone >1.5mg; or another immunosuppressive agent Note: Topical or inhaled corticosteroids are allowed
  • Other active malignancy other than breast cancer requiring systemic therapy
  • Pregnant or lactating
  • Co-enrollment in another clinical trial Note: Patients may co-enroll in other clinical trial(s) if the trial(s) does not interfere with the objectives of this trial
  • Significant psychiatric illness, in the opinion of the investigator, that would limit compliance with study requirements
  • Any active suicidality or history of active suicidal ideation/behavior/attempt within 1 year prior to screening
  • Any other condition that, in the opinion of the investigator, would make the patient unsuitable for study participation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Niraj Shah, MS contact

317-278-3420

shahnir@iu.edu

United States1 site

  • Indiana University Melvin and Bren Simon Comprehensive Cancer Center

    Indianapolis, Indiana, 46202

    Niraj Shah, MS, 317-278-3420, shahnir@iu.edu

    Tarah Ballinger, MD

Other trials in United States

About this study

Official title: A Phase II Single-Arm Pilot Study of Hydroxychloroquine for the Treatment of Aromatase Inhibitor-Associated Musculoskeletal Syndrome

The purpose of this study is to evaluate the effectiveness of hydroxychloroquine sulfate (a type of drug commonly used to treat joint pain caused by inflammation, swelling) in reducing joint pain associated with Aromatase Inhibitor Associated Musculoskeletal Syndrome (AIMSS) for patients with breast cancer.

Read the detailed description

Aromatase Inhibitor (AI) therapy is highly effective for post-menopausal, estrogen receptor (ER) positive breast cancer, yet the clinical effectiveness of AI therapy is limited by noncompliance and early treatment discontinuation due to musculoskeletal side effects, which include joint pain, joint stiffness, bone pain, muscle weakness, and myalgias. Methods to improve compliance to AI therapy have the potential to increase survival.

This study will look at hydroxychloroquine (HCQ), a disease-modifying antirheumatic drug (DMARD) with well-established anti-inflammatory and immunomodulatory properties. It is FDA-approved for the treatment of conditions characterized by chronic inflammatory joint pain similar to AIMSS. This single-arm, proof of concept study will look for an improvement in joint pain for patients undergoing standard of care treatment involving AI therapy.

Being tested
Hydroxychloroquine Sulfate (HCQ)
Keywords
Hydroxychloroquine, Joint Pain, Aromatase Inhibitor Associated Musculoskeletal Symptoms (AMISS)
Medical subject headings
Arthralgia, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hydroxychloroquine Sulfate (HCQ)Drug

    Drug: Hydroxychloroquine sulfate Dose: 400 mg orally once daily Duration: 12 weeks

Study groups in NCT07825454
Study groupRoleWhat they receive
Hydroxychloroquine sulfateExperimentalHydroxychloroquine sulfate, 400 mg orally once daily
Receives: Drug: Hydroxychloroquine Sulfate (HCQ)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the efficacy of hydroxychloroquine

    To evaluate the efficacy of hydroxychloroquine 400 mg daily in reducing joint pain associated with AIMSS as measured by change in Brief Pain Inventory (BPI) Average Pain score (scored from 0-10; a minimally important difference is a 2-point reduction or 30% from baseline).

    Measured: Day 1 and Week 12

Secondary outcomes (8)

  1. Proportion of patients achieving a clinically meaningful improvement

    To assess the proportion of patients achieving a clinically meaningful improvement (≥2-point reduction) in BPI Average Pain score.

    Measured: Day 1 and Week 12

  2. Changes in BPI Worst Pain and Pain Interference scores

    To evaluate changes in BPI Worst Pain and Pain Interference scores (scored from 0-10; a minimally important difference is a 2-point reduction or 30% from baseline).

    Measured: Day 1 and Week 12

  3. Changes in endocrine therapy related quality of life

    To assess changes in endocrine therapy related quality of life by FACT-ES (5 point Likert-type scale).

    Measured: Day 1 and Week 12

  4. Changes in grip strength

    To assess changes in grip strength as an objective measure of function using Jamar hand dynamometers (scale of 0-200lbs).

    Measured: Day 1 and Week 12

  5. Patient-reported global impression of change

    To evaluate patient-reported global impression of change using the Patient Global Impression of Change (PGIC) (scale 0-6, 6 being the worst outcome).

    Measured: Week 12

  6. Safety of hydroxychloroquine in this patient population

    To assess safety of hydroxychloroquine in this patient population using NCI CTCAE v5.0 (grade 1-5, 5 being the worst outcome).

    Measured: Day 1, Week 4, Week 12, 30 days post EOT

  7. Tolerability of hydroxychloroquine in this patient population

    To assess tolerability of hydroxychloroquine in this patient population via number of patients who completed treatment.

    Measured: Day 1, Week 4, Week 12, 30 days post EOT

  8. Adherence to aromatase inhibitor therapy

    To evaluate adherence to aromatase inhibitor therapy during the study period via number of patients who completed treatment based on self-report.

    Measured: Screening, Day 1, and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Sep 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07825454
Sponsor's protocol ID
CTO-IUSCCC-0959
Acronym
AIMSS
Status last verified
Sep 2026
First submitted
25 Aug 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Hydroxychloroquine Sulfate (HCQ) in people with Aromatase Inhibitor Associated Musculoskeletal Symptoms (AIMSS) and Joint Pain, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Niraj Shah, MS (317-278-3420, shahnir@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the efficacy of hydroxychloroquine (time frame: Day 1 and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07825454.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in