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AzTrials

Hormone Receptor-Positive and HER2-Negative Advanced Breast CancerPhase 3NCT07061717

Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

A Phase 3 study testing Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid and Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid in people with Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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

This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone receptor-positive and her2-negative advanced breast cancer. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid and Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
474 participants
Where
1 siteChina
Study dates
1 Jul 2025to 1 Jul 2029
Phase
Phase 3
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 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntary participation in this study and signed informed consent.
  • Female (aged ≥18 and ≤70 years), histologically or cytologically diagnosed as HER2-negative (based on ASCO/CAP guidelines: HER2 IHC 2+/FISH negative, IHC 1+ or IHC 0), hormone receptor-positive (based on ASCO/CAP guidelines: ER ≥1%) breast cancer, with evidence of locally recurrent or metastatic disease that is not suitable for surgical resection or curative radiotherapy.
  • Locally recurrent or metastatic breast cancer that has not received any prior systemic anticancer treatment.
  • Presence of measurable lesions according to RECIST v.1.1, or isolated bone lesions. Tumor lesions previously treated with radiation or other local therapies are considered measurable only if disease progression at the treated site is clearly documented after completion of therapy.
  • ECOG performance status of 0-1.
  • Sufficient bone marrow function reserve: white blood cell count ≥3.0×10⁹/L, neutrophil count ≥1.5×10⁹/L, platelet count ≥100×10⁹/L, hemoglobin ≥90 g/L.
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  • Sufficient liver and kidney function reserve: AST and ALT ≤3 times the upper limit of normal (5 times in the case of liver metastasis), total bilirubin ≤1.5 times the upper limit of normal (3 times in case of Gilbert's syndrome), serum creatinine and urea nitrogen ≤1.5 times the upper limit of normal.
  • All acute toxicities from prior anticancer treatments or surgical interventions have resolved to ≤Grade 1 according to NCI-CTCAE v.5.0 (alopecia or other toxicities that are not considered to pose a safety risk, in the investigator's judgment, are exceptions).
  • Willing and able to comply with scheduled visits.

Who cannot join

  • Presence of complications that the investigator considers may become life-threatening in the short term (including massive effusions (pleural effusion, pericardial effusion, ascites), carcinomatous lymphangitis, liver involvement exceeding 50%).
  • Known, uncontrolled clinical symptoms, brain edema and/or progressive growth of symptomatic central nervous system metastases, carcinomatous meningitis, or meningeal disease.
  • Any major surgery, chemotherapy, radiotherapy, any investigational drug or other anticancer treatments within 2 weeks prior to randomization. Patients who have received >25% bone marrow irradiation, regardless of the timing of the radiotherapy, are excluded.
  • Diagnosis of any other malignancy within 3 years prior to randomization, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or cervical carcinoma in situ.
  • QTc >480 milliseconds (based on electrocardiogram), or a family or personal history of long QT syndrome, short QT syndrome, Brugada syndrome, or known QTc prolongation, or history of Torsades de Pointes (TdP).
  • Presence of uncontrolled electrolyte disturbances that may exacerbate the effects of QTc prolonging drugs (e.g., hypocalcemia, hypokalemia, hypomagnesemia).
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  • Within 6 months after randomization, the occurrence of any of the following: myocardial infarction, severe/uncontrolled angina, NCI-CTCAE v.5.0 Grade 2 persistent arrhythmias, any degree of atrial fibrillation, coronary/peripheral artery bypass surgery, asymptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or asymptomatic pulmonary embolism.
  • Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery (including gastrectomy).
  • Known allergy to anastrozole, letrozole, exemestane/hydroxychloroquine/palbociclib, or any excipients of these agents.
  • Known human immunodeficiency virus infection.
  • Participation in another clinical study involving investigational drugs during the active treatment phase of this trial.
  • Positive for HBV surface antigen with high HBV DNA copy number (except for those with low copy number (≤103/ml) after antiviral treatment).
  • Ophthalmologic examination revealing any of the following eye conditions: retinopathy, visual field defects, etc.
  • Any other severe acute or chronic medical or psychiatric conditions, or laboratory abnormalities, which may increase the risk associated with participation in the study or the use of the investigational product, or which may interfere with the interpretation of study results, and in the investigator's judgment, would make the patient unsuitable for participation in the study.

Trial locations and contacts

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

Chang Gong contact

02034070499

gchang@mail.sysu.edu.cn

China1 site

  • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

    Guangzhou, Guangdong

    Chang Gong, 02034070499, gchang@mail.sysu.edu.cn

Other trials in China

About this study

Official title: A Phase III, Randomized, Open-Label Clinical Trial Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer

This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone receptor-positive and her2-negative advanced breast cancer.

Being tested
Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid

What participants receive

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

  • Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qdDrug

    Standard-Dose Palbociclib + Endocrine therapy

  • Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bidDrug

    Standard-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine

  • Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bidDrug

    High-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine

Study groups in NCT07061717
Study groupRoleWhat they receive
Control Group1Active comparatorStandard-Dose Palbociclib + Endocrine therapy
Receives: Drug: Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd
Experimental Group 1ExperimentalStandard-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine
Receives: Drug: Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid
Experimental Group 2ExperimentalHigh-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine
Receives: Drug: Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid

What is being measured

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

  1. Progression-Free Survival (PFS) as Assessed by the Investigator

    Measured: 3 years after random assignment

Secondary outcomes (6)

  1. Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)

    Measured: 3 years after random assignment

  2. Overall Survival (OS)

    Measured: 3 years after random assignment

  3. Objective Response Rate (ORR)

    Measured: 3 years after random assignment

  4. Clinical Benefit Rate (CBR)

    Measured: 6 months after random assignment

  5. Treatment Associated Adverse Effect

    Measured: 3 years after random assignment

  6. Patient-Reported Outcomes (PRO)

    Measured: 3 years after random assignment

Timeline

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

  1. First posted11 Jul 2025
  2. Study start1 Jul 2025 (estimated)
  3. Primary completion1 Jul 2029 (estimated)
  4. Study completion1 Jul 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
474 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07061717
Sponsor's protocol ID
SYSKY-2025-424-01
Status last verified
Jul 2025
First submitted
28 May 2025
Last updated
11 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid and Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid in people with Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

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: opening soon, as of the sponsor's last update on 11 Jul 2025. 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 China. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 Chang Gong (02034070499, gchang@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-Free Survival (PFS) as Assessed by the Investigator (time frame: 3 years after random assignment). 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 NCT07061717.

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 11 Jul 2025.

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