Estrogen Receptor Positive Breast CancerPhase 1ABC01NCT02414776
Hydroxychloroquine in Metastatic Estrogen Receptor-Positive Breast Cancer Progressing on Hormonal Therapy
A Phase 1 study testing hydroxychloroquine in people with Estrogen Receptor Positive Breast Cancer, run by Western Regional Medical Center at 1 site in United States.
Trial summary
To determine the safety and tolerability of orally administered hydroxychloroquine with hormonal therapy. To assess the response rate of hydroxychloroquine in combination with hormonal therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Estrogen Receptor Positive Breast Cancer
- What is being tested?
- hydroxychloroquine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Nov 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients ≥ 18 years of age with histologically confirmed, metastatic ER + breast cancer with clinical progression of disease (including radiographically stable disease with at least 50% increment of an elevated tumor marker by two measurements at least 2 weeks apart (this particular tumor marker will be used for disease status assessment in the study) on current hormonal therapy with PFS for at least 3 months.
- Karnofsky Performance Status (KPS) ≥70% and a life expectancy >3 months.
- Participants must have at least one target visceral lesion that allows for evaluation of tumor response or in the case of bone-only metastases, patients need to have a positive imaging study such as bone scan, magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) or CT, and an elevated tumor marker at least twice as high as upper limit.
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 80×109 L, hemoglobin ≥ 8.5 g/dL
- Creatinine clearance ≥ 30 mL/min, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 3 times the upper limit of normal range
- No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator
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- At least two (2) weeks from prior major surgery
- Willingness to provide permission to biopsy one of the lesions if applicable before the study (All the patients are encouraged to have post-therapy biopsy upon progression of disease, but it is optional) as well as blood samples for pertinent laboratory studies
- Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable non-hormonal contraceptive method (abstinence, or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial -
Who cannot join
- On combination hormonal therapy with everolimus or any other investigational agent
- Patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid 18Jul2014 Protocol v3: ABC 01 Anti-Autophagy for Met Breast Cancer Page 4 of 16
- Lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
- Lactating females
- Uncontrolled cardiac disease, congestive heart failure, angina or hypertension
- Myocardial infarction or unstable angina within 2 months of treatment
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- Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol)
- Active clinically serious infection > CTCAE (version 4.03) Grade 2
- Serious non-healing wound, ulcer, or bone fracture
- Concurrent psychiatric illness/social situations that would limit safety and compliance with study requirements
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
- Currently receiving any other investigational therapeutic agents
- Patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, cirrhosis or any other conditions with potential significant known risks
- Patients with history of retinal damage
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Regional Medical Center, Inc.
Goodyear, Arizona, 85338
About this study
Official title: Phase Ib/II Study of Hydroxychloroquine in Metastatic ER-Positive Breast Cancer Progressing on Hormonal Therapy
To determine the safety and tolerability of orally administered hydroxychloroquine with hormonal therapy.
To assess the response rate of hydroxychloroquine in combination with hormonal therapy.
Read the detailed description
To determine the number of patients with adverse effects
To assess the clinical response to the combination
- Conditions
- Estrogen Receptor Positive Breast Cancer
- Being tested
- hydroxychloroquine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
administration of hydroxychloroquine in combination with the current hormonal therapy
| Study group | Role | What they receive |
|---|---|---|
| hydroxychloroquine plus hormonal therapy | Experimental | Add hydroxychloroquine to the current hormonal therapy Receives: Drug: hydroxychloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of the safety profile of orally administered hydroxychloroquine with hormonal therapy
Assess the dose-limiting side effects such as neutropenia, anemia, or thormbocytopenia, or non-hematologic side effects nausea, vomiting, diarrhea, or vision problems at the study dose
Measured: 18 months
Secondary outcomes (4)
The recommended phase 2 clinical dose (RP2D) of orally administered hydroxychloroquine with hormonal therapy
orally administered hydroxychloroquine with hormonal therapy
Measured: 18 months
The pharmacodynamic (PD) profile of hydroxychloroquine with hormonal therapy
microtubule-associated protein 1 light chain 3 b (LC3b) level in the biopsy, WBCs in pre- and post-treatment samples
Measured: 18 months
The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD)
The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD)
Measured: 18 months
The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy
The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2015 (estimated)
- Study startJul 2014
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: PI Leaving Site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Estrogen Receptor Positive Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jiaxin Niu, MD, PhD, Principal investigator, Western Regional Medical Center, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414776
- Sponsor's protocol ID
- WIRB 20140460
- Acronym
- ABC01
- Status last verified
- Sep 2017
- First submitted
- 19 Jan 2015
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Study of Hydroxychloroquine in Metastatic ER-Positive Breast Cancer Progressing on Hormonal Therapy
- ClinicalTrials.gov ID
- NCT02414776
- Acronym / sponsor ID
- ABC01 / WIRB 20140460
- Conditions
- Estrogen Receptor Positive Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Leaving Site
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Western Regional Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 13 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine the safety and tolerability of orally administered hydroxychloroquine with hormonal therapy.
To assess the response rate of hydroxychloroquine in combination with hormonal therapy.
Detailed description
To determine the number of patients with adverse effects
To assess the clinical response to the combination
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hydroxychloroquine plus hormonal therapy | Experimental | Drug: hydroxychloroquineAdd hydroxychloroquine to the current hormonal therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients ≥ 18 years of age with histologically confirmed, metastatic ER + breast cancer with clinical progression of disease (including radiographically stable disease with at least 50% increment of an elevated tumor marker by two measurements at least 2 weeks apart (this particular tumor marker will be used for disease status assessment in the study) on current hormonal therapy with PFS for at least 3 months.
- Karnofsky Performance Status (KPS) ≥70% and a life expectancy >3 months.
- Participants must have at least one target visceral lesion that allows for evaluation of tumor response or in the case of bone-only metastases, patients need to have a positive imaging study such as bone scan, magnetic resonance imaging (MRI) or positron emission tomography-computed tomography (PET-CT) or CT, and an elevated tumor marker at least twice as high as upper limit.
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 80×109 L, hemoglobin ≥ 8.5 g/dL
- Creatinine clearance ≥ 30 mL/min, total bilirubin ≤ 2 mg/dL, AST/ALT ≤ 3 times the upper limit of normal range
Key exclusion criteria (14 listed)
- On combination hormonal therapy with everolimus or any other investigational agent
- Patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid 18Jul2014 Protocol v3: ABC 01 Anti-Autophagy for Met Breast Cancer Page 4 of 16
- Lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
- Lactating females
- Uncontrolled cardiac disease, congestive heart failure, angina or hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydroxychloroquineAlso: Plaqueniladministration of hydroxychloroquine in combination with the current hormonal therapy | Drug | hydroxychloroquine plus hormonal therapy |
Primary outcome
Number of Participants with Adverse Events as a Measure of the safety profile of orally administered hydroxychloroquine with hormonal therapy
Time frame: 18 months
Assess the dose-limiting side effects such as neutropenia, anemia, or thormbocytopenia, or non-hematologic side effects nausea, vomiting, diarrhea, or vision problems at the study dose
4 secondary outcomes
The recommended phase 2 clinical dose (RP2D) of orally administered hydroxychloroquine with hormonal therapy
Time frame: 18 months
The pharmacodynamic (PD) profile of hydroxychloroquine with hormonal therapy
Time frame: 18 months
The anti-tumor activity of hydroxychloroquine with hormonal therapy with clinical benefit rate (CBR). Clinical benefits are defined as complete remission (CR), partial remission (PR) and stable disease (SD)
Time frame: 18 months
The disease-free survival (DFS) when adding hydroxychloroquine to hormonal therapy
Time frame: 18 months
Results and safety
The study was stopped early (reason given: PI Leaving Site). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiaxin Niu, MD, PhD principal investigator
Western Regional Medical Center, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hydroxychloroquine in people with Estrogen Receptor Positive Breast Cancer, run by Western Regional Medical Center 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 9 inclusion and 14 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: stopped early, as of the sponsor's last update on 27 Sep 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: PI Leaving Site). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of the safety profile of orally administered hydroxychloroquine with hormonal therapy (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2017.