HR Positive/HER2 Negative Advanced or Metastatic Breast CancerPhase 3NCT07393321

A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer

A Phase 3 study testing NTQ1062+Fulvestrant in people with HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer, run by Nanjing Chia-tai Tianqing Pharmaceutical.

Not yet recruiting

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

Official record

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Trial summary

NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with fulvestrant in patients with HR positive, HER2 negative, locally advanced (unresectable) or… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
What is being tested?: NTQ1062+Fulvestrant
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 210 participants
Where: No sites listed yet
Study dates: 10 Feb 2026to 31 Aug 2031
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

(1) Adult female or male subjects who sign the informed consent form and are at least 18 years of age at the time of signing; (2) pre- and/or post-menopausal women are eligible for inclusion. Premenopausal women must receive ovarian function suppression treatment during the study, such as gonadotropin-releasing hormone agonists (GnRHa). Menopause is defined as: prior bilateral oophorectomy; age ≥ 60 years; age < 60 years, with amenorrhea for ≥ 12 months without prior chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy, and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal reference range; (3) Histologically confirmed HR positive, HER-2-negative recurrent locally advanced or metastatic breast cancer, as determined by testing of a recent tumor sample; (4) Prior treatment with at least one endocrine therapy regimen (monotherapy or combination therapy, including aromatase inhibitors and selective ER modulators); (5) Subjects must have at least one measurable disease lesion assessable by CT or MRI, or at least one osteolytic or mixed (osteolytic + sclerotic) bone lesion at baseline; (6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (7) No contraindications to fulvestrant, and meets the eligibility requirements for fulvestrant treatment, as assessed by the investigator; (8) Expected survival time of more than 6 months, as assessed by the investigator; (9) Good bone marrow reserve and organ function; (10) Premenopausal women must have a negative pregnancy test before administration and agree to use effective contraception during the trial and for at least 6 months after the last dose.

Who cannot join

unsuitable for endocrine anti-tumor therapy by the investigators, such as symptomatic visceral crises or inflammatory breast cancer that may be life-threatening in the short term;
unable to take oral medication, or with severe gastrointestinal disorders that may affect drug absorption, such as intractable nausea and vomiting, chronic diarrhea (diarrhea lasting >4 weeks), or intestinal obstruction;
clinically significant glucose metabolism abnormalities, defined as: diagnosed with type 1 diabetes; type 2 diabetes requiring insulin treatment; glycated hemoglobin (HbA1c) ≥8%; fasting blood glucose >9.3 mmol/L in patients with history of type 2 diabetes, or fasting blood glucose >7.0 mmol/L in patients without history of diabetes;
prior use of fulvestrant or other selective estrogen receptor degraders (SERDs) or any PI3K/mTOR/Akt inhibitors;
other malignancies besides breast cancer within 5 years prior to screening (excluding basal or squamous cell skin cancer, papillary thyroid carcinoma, bladder carcinoma in situ, or cervical carcinoma in situ, or other tumors that have been radically treated and have shown no clinical recurrence for at least 5 years);
have undergone major surgery within 28 days prior to the first dose;

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have participated in other interventional clinical studies of unmarketed products within 28 days prior to the first dose;
severe infections requiring systemic intravenous antibiotics within 28 days prior to the first dose;
have received >30% bone marrow radiotherapy or extensive radiotherapy within 28 days prior to the first dose, or palliative local radiotherapy (such as thoracic spine and rib radiotherapy) within 14 days prior to the first dose;
have received chemotherapy, endocrine therapy, CDK4/6 inhibitors, traditional Chinese medicine with clear anti-tumor indications, or other small molecule targeted anti-tumor drugs within 14 days prior to the first dose or within 5 half-lives of the drug (whichever is shorter);
Received potent CYP3A inhibitors or potent CYP3A inducers within 14 days before the first dose;
Previous anti-tumor treatment-related toxicities have not recovered to ≤ grade 1 (assessed according to CTCAE 5.0 criteria, excluding indicators required by the inclusion criteria and toxicities judged by the investigator to pose no safety risk, such as alopecia, grade 2 peripheral neuropathy, and hypothyroidism stabilized by hormone replacement therapy);
Known active central nervous system (CNS) metastases, including symptomatic brain metastases, leptomeningeal metastases, or spinal cord compression. Patients who are asymptomatic or stable after treatment and do not require steroid treatment are eligible for enrollment, provided that imaging studies during the screening period confirm no progression for at least 4 weeks;
History of interstitial lung disease, drug-induced interstitial lung disease, or radiation pneumonitis requiring steroid treatment, or any evidence of clinically active interstitial lung disease;
History of severe cardiovascular or cerebrovascular disease;
active hepatitis, defined as positive for hepatitis B surface antigen (HBsAg) and HBV DNA titer above the local laboratory's lower limit of detection; or positive for hepatitis C virus (HCV) antibody and HCV RNA above the local laboratory's lower limit of detection;
History of positive human immunodeficiency virus (HIV) test or positive HIV antibody test result;
Clinically uncontrollable pleural, abdominal, or pericardial effusion requiring repeated drainage at the time of screening;
Allergy to any active or inactive ingredient of NTQ1062, fulvestrant, or LHRH agonists;
Presence of pre-existing or concomitant diseases that the investigator believes may interfere with trial compliance;
Pregnant or breastfeeding women.

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of NTQ1062 in Combination With Fulvestrant Versus Placebo Plus Fulvestrant in Patients With Locally Advanced (Unresectable) or Metastatic HR+/HER2- Breast Cancer Who Relapsed or Progressed During or After Endocrine Therapy.

Conditions: HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
Being tested: Placebo + fulvestrant, NTQ1062+Fulvestrant
Medical subject headings: Breast Neoplasms

What participants receive

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

Placebo + fulvestrantDrug
Placebo: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle.
Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.
NTQ1062+FulvestrantDrug
NTQ1062: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle.
Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.

Study groups in NCT07393321
Study group	Role	What they receive
placebo+ fulvestrant	Placebo comparator	Placebo: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter. Receives: Drug: Placebo + fulvestrant
NTQ1062+fulvestrant	Experimental	NTQ1062: 200 mg orally twice daily for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day15 of cycle 1, and then on Day 1 of each cycle thereafter. Receives: Drug: NTQ1062+Fulvestrant

What is being measured

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

Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1
Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1, defined as the time from randomization to the date of disease progression or death from any cause.
Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

Secondary outcomes (5)

PFS assessed by BICR according to RECIST v1.1.
PFS assessed by BICR according to RECIST v1.1.
Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Overall survival (OS) defined as the time from randomization to the date of death from any cause.
Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Duration of response (DoR), defined as the time from the date of first recorded response to the date of documented disease progression or the date of death in the absence of documented progression.
Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter
Disease control rate (DCR), defined as the percentage of subjects achieving CR, PR, or stable disease (SD) per RECIST v1.1
Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Clinical benefit rate (CBR), defined as the percentage of patients achieving CR, PR, or stable disease (without subsequent anticancer therapy) per RECIST v1.1
Measured: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

Timeline

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

10 Feb 202631 Aug 2031

First posted6 Feb 2026
Study start10 Feb 2026 (estimated)
Primary completion31 Aug 2028 (estimated)
Study completion31 Aug 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HR Positive/HER2 Negative Advanced or Metastatic 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 210 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07393321
Sponsor's protocol ID: NTQ1062-301
Status last verified: Jan 2026
First submitted: 16 Jan 2026
Last updated: 6 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase III Trial to Evaluate the Efficacy and Safety of NTQ1062 in Combination With Fulvestrant Versus Placebo Plus Fulvestrant in Patients With Locally Advanced (Unresectable) or Metastatic HR+/HER2- Breast Cancer Who Relapsed or Progressed During or After Endocrine Therapy.
ClinicalTrials.gov ID: NCT07393321
Acronym / sponsor ID: NTQ1062-301
Conditions: HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 210 participants (estimated)
Lead sponsor: Nanjing Chia-tai Tianqing PharmaceuticalIndustry (pharma, biotech, devices)
Study start: 10 Feb 2026 (estimated)
Primary completion: 31 Aug 2028 (estimated)
Study completion: 31 Aug 2031 (estimated)
First posted: 6 Feb 2026 (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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
placebo+ fulvestrant	Placebo comparator	Drug: Placebo + fulvestrantPlacebo: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.
NTQ1062+fulvestrant	Experimental	Drug: NTQ1062+FulvestrantNTQ1062: 200 mg orally twice daily for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day15 of cycle 1, and then on Day 1 of each cycle thereafter.

Who may qualify

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

Key inclusion criteria (1 listed)

(1) Adult female or male subjects who sign the informed consent form and are at least 18 years of age at the time of signing; (2) pre- and/or post-menopausal women are eligible for inclusion. Premenopausal women must receive ovarian function suppression treatment during the study, such as gonadotropin-releasing hormone agonists (GnRHa). Menopause is defined as: prior bilateral oophorectomy; age ≥ 60 years; age < 60 years, with amenorrhea for ≥ 12 months without prior chemotherapy, tamoxifen, toremifene, or ovarian suppression therapy, and follicle-stimulating hormone (FSH) and estradiol levels within the postmenopausal reference range; (3) Histologically confirmed HR positive, HER-2-negative recurrent locally advanced or metastatic breast cancer, as determined by testing of a recent tumor sample; (4) Prior treatment with at least one endocrine therapy regimen (monotherapy or combination therapy, including aromatase inhibitors and selective ER modulators); (5) Subjects must have at least one measurable disease lesion assessable by CT or MRI, or at least one osteolytic or mixed (osteolytic + sclerotic) bone lesion at baseline; (6) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; (7) No contraindications to fulvestrant, and meets the eligibility requirements for fulvestrant treatment, as assessed by the investigator; (8) Expected survival time of more than 6 months, as assessed by the investigator; (9) Good bone marrow reserve and organ function; (10) Premenopausal women must have a negative pregnancy test before administration and agree to use effective contraception during the trial and for at least 6 months after the last dose.

Key exclusion criteria (21 listed)

unsuitable for endocrine anti-tumor therapy by the investigators, such as symptomatic visceral crises or inflammatory breast cancer that may be life-threatening in the short term;
unable to take oral medication, or with severe gastrointestinal disorders that may affect drug absorption, such as intractable nausea and vomiting, chronic diarrhea (diarrhea lasting >4 weeks), or intestinal obstruction;
clinically significant glucose metabolism abnormalities, defined as: diagnosed with type 1 diabetes; type 2 diabetes requiring insulin treatment; glycated hemoglobin (HbA1c) ≥8%; fasting blood glucose >9.3 mmol/L in patients with history of type 2 diabetes, or fasting blood glucose >7.0 mmol/L in patients without history of diabetes;
prior use of fulvestrant or other selective estrogen receptor degraders (SERDs) or any PI3K/mTOR/Akt inhibitors;
other malignancies besides breast cancer within 5 years prior to screening (excluding basal or squamous cell skin cancer, papillary thyroid carcinoma, bladder carcinoma in situ, or cervical carcinoma in situ, or other tumors that have been radically treated and have shown no clinical recurrence for at least 5 years);

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
Placebo + fulvestrantPlacebo: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.	Drug	placebo+ fulvestrant
NTQ1062+FulvestrantNTQ1062: 200 mg orally twice daily, for 21 consecutive days, followed by 7 days off (21/7 dosing schedule), during a 28-day cycle. Fulvestrant: 2 intramuscular injections of 500 mg given on Day 1 and Day 15 of cycle 1, and then on Day 1of each cycle thereafter.	Drug	NTQ1062+fulvestrant

Primary outcome

Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1
Time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1, defined as the time from randomization to the date of disease progression or death from any cause.

5 secondary outcomes

PFS assessed by BICR according to RECIST v1.1.
Time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Overall survival (OS) defined as the time from randomization to the date of death from any cause.
Time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Duration of response (DoR), defined as the time from the date of first recorded response to the date of documented disease progression or the date of death in the absence of documented progression.
Time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter
Disease control rate (DCR), defined as the percentage of subjects achieving CR, PR, or stable disease (SD) per RECIST v1.1
Time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.
Clinical benefit rate (CBR), defined as the percentage of patients achieving CR, PR, or stable disease (without subsequent anticancer therapy) per RECIST v1.1
Time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.

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 6 Feb 2026.

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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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NTQ1062+Fulvestrant in people with HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer, run by Nanjing Chia-tai Tianqing Pharmaceutical.

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 1 inclusion and 21 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 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

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?

Progression-free survival (PFS) as assessed by investigators according to RECIST v1.1 (time frame: From date of inclusion until the date of first documented progression, assessed up to 60 months. Assessed every 8 weeks for the first 12 months and every 12 weeks thereafter.). 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 NCT07393321.

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 6 Feb 2026.