Advanced ER+/HER2- Breast CancerPhase 1/2NCT07235176

Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients

A Phase 1/2 study testing QLS1304 tablet+Fulvestrant or QLC1401 and QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i in people with Advanced ER+/HER2- Breast Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced ER+/HER2- Breast Cancer
What is being tested?: QLS1304 tablet+Fulvestrant or QLC1401 and QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 1 siteChina
Study dates: 16 Jan 2026to 30 Dec 2031
Phase: Phase 1/2
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

Volunteer to participate in this study, sign an informed consent form and have good compliance;
Age ≥ 18 years old, Male or female
ECOG score: 0-1
Expected survival ≥ 12 weeks
Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;
Failed to at least one therapy line of endocrine therapy ;

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Baseline presence of at least one measurable lesion according to the RECIST v1.1;
The functional level of important organs is basically normal, meeting the requirements of the scheme;
Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent.

Who cannot join

Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
Subjects require long-term or high-dose use of non-steroidal drugs.
Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
Subjects have a known or suspected severe allergy to the investigational drug or any of its components.
Subjects have other active malignant tumors within 3 years before the first use of the investigational drug.

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Subjects have brain metastases and/or carcinomatous meningitis or leptomeningeal disease.
Subjects have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or other diseases, symptoms, or signs of severe lung function impairment.
Subjects are unable to swallow tablets or had gastrointestinal abnormalities that the investigator assessed as potentially affecting drug absorption.
Subjects have a history of severe cardiovascular or cerebrovascular disease within 6 months before the first use of the investigational drug.
Subjects have a hypertension medial history that blood is not well controlled despite treatment with multiple antihypertension drugs.

Trial locations and contacts

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

China1 site, 1 recruiting

Fudan University Cancer Hospital
Shanghai
Jian Zhang, 021-34778299, syner2000@163.com
Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients

Conditions: Advanced ER+/HER2- Breast Cancer
Being tested: QLS1304 tablet+Fulvestrant or QLC1401, QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i

What participants receive

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

QLS1304 tablet+Fulvestrant or QLC1401Drug
QLS1304 combined with endocrine therapy
QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6iDrug
QLS1304 combined with endocrine therapy

Study groups in NCT07235176
Study group	Role	What they receive
QLS1304 tablet + SERD	Experimental	Not described Receives: Drug: QLS1304 tablet+Fulvestrant or QLC1401
QLS1304 tablet + ET+CDK4/6i	Experimental	Not described Receives: Drug: QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i

What is being measured

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

Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy
Measured: through study completion，an average of 2 years
objective response rate（ORR）
Measured: through study completion，an average of 2 years

Timeline

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

16 Jan 202630 Dec 2031

First posted19 Nov 2025
Study start16 Jan 2026
Primary completion2 Nov 2028 (estimated)
Study completion30 Dec 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced ER+/HER2- Breast CancerStudies of the same condition, open and under way.
More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
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 1/2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 300 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07235176
Sponsor's protocol ID: QLS1304-201
Status last verified: Nov 2025
First submitted: 14 Nov 2025
Last updated: 22 May 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingPhase 2
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Inflammatory Breast Cancer, Stage IIA Breast Cancer

All Advanced ER+/HER2- Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients
ClinicalTrials.gov ID: NCT07235176
Acronym / sponsor ID: QLS1304-201
Conditions: Advanced ER+/HER2- Breast Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 300 participants (estimated)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 16 Jan 2026 (actual)
Primary completion: 2 Nov 2028 (estimated)
Study completion: 30 Dec 2031 (estimated)
First posted: 19 Nov 2025 (actual)
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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
QLS1304 tablet + SERD	Experimental	Drug: QLS1304 tablet+Fulvestrant or QLC1401
QLS1304 tablet + ET+CDK4/6i	Experimental	Drug: QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Volunteer to participate in this study, sign an informed consent form and have good compliance;
Age ≥ 18 years old, Male or female
ECOG score: 0-1
Expected survival ≥ 12 weeks
Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;

Key exclusion criteria (11 listed)

Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
Subjects require long-term or high-dose use of non-steroidal drugs.
Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
Subjects have a known or suspected severe allergy to the investigational drug or any of its components.

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
QLS1304 tablet+Fulvestrant or QLC1401QLS1304 combined with endocrine therapy	Drug	QLS1304 tablet + SERD
QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6iQLS1304 combined with endocrine therapy	Drug	QLS1304 tablet + ET+CDK4/6i

Primary outcome

Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy
Time frame: through study completion，an average of 2 years
objective response rate（ORR）
Time frame: through study completion，an average of 2 years

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.

Related trials for Advanced ER+/HER2- Breast Cancer

RecruitingPhase 2
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
RecruitingPhase 1
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
Active, not recruitingPhase 3
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
Active, not recruitingPhase 2
Carboplatin and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Locally Advanced or Inflammatory Triple Negative Breast Cancer
Inflammatory Breast Cancer, Stage IIA Breast Cancer

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.

Fudan University Cancer Hospital

Shanghai, China

021-34778299

syner2000@163.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 May 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 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 combined 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy (time frame: through study completion，an average of 2 years). The study lists 2 primary outcomes in all. 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 NCT07235176.

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 22 May 2026.