Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast CancerPhase 3NCT04842617

Phase III Study ：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative

A Phase 3 study testing SHR6390 in people with Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative. Read more about this study

Who is it for?: Ages 18 to 75 years, women only
Conditions the study is for: Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
What is being tested?: SHR6390
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 5,274 participants
Where: 1 siteChina
Study dates: 30 Apr 2021to 31 Oct 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 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old.
Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-.
Underwent radical resection of breast cancer.
The score of ECOG was 0 - 1.
Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures.
With my consent and informed consent, I am willing and able to comply with the planned visit, study treatment plan, laboratory examination and other test procedures.

Who cannot join

This Pathological examination diagnosed as HER2-positive breast cancer.
The history of any malignant tumor other than breast cancer within 5 years before randomization.
At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.).
In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc
Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.
There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind Phase III Study：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer

The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

To observe the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

Conditions: Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Being tested: SHR6390, placebo

What participants receive

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

SHR6390Drug
SHR6390 combined with endocrine therapy
placeboDrug
placebo combined with endocrine therapy

Study groups in NCT04842617
Study group	Role	What they receive
Treatment group A	Experimental	Not described Receives: Drug: SHR6390
Treatment group B	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

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

IDFS（Invasive Disease-Free Survival）
Measured: at least 5 years from the date of randomization .

Secondary outcomes (5)

DFS(Disease-Free Survival)
Measured: The observation time is at least 5 years from the date of randomization . Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.
OS(Overall Survival)
Measured: up to approximately 5 years.
DDFS(Distant Disease-Free Survival)
Measured: from randomization to distant recurrence or death from any cause, whichever occurs first. Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.
Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
To evaluate the safety and tolerability of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative female breast cancer.
Measured: up to approximately 5 years
Plasma concentration of SHR6390 will be analyzed for PK samples
To explore the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative female breast cancer.
Measured: collected on day 1 of the 5th, 9th, 13th and 17th weeks, respectively.

Timeline

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

30 Apr 202131 Oct 2031

First posted13 Apr 2021
Study start30 Apr 2021
Primary completion31 Oct 2026 (estimated)
Study completion31 Oct 2031 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast CancerStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: SHR6390 Tablets compared with placebo
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 5,274 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04842617
Sponsor's protocol ID: SHR6390-III-303
Status last verified: Jul 2024
First submitted: 30 Mar 2021
Last updated: 1 Aug 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-blind Phase III Study：SHR6390/Placebo Combined With Endocrine Therapy for the Adjuvant Treatment of Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
ClinicalTrials.gov ID: NCT04842617
Acronym / sponsor ID: SHR6390-III-303
Conditions: Hormone Receptor Positive,Human Epidermal Receptor 2 Negative, Node-positive, High Risk, Early Stage，Female Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 5,274 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 30 Apr 2021 (actual)
Primary completion: 31 Oct 2026 (estimated)
Study completion: 31 Oct 2031 (estimated)
First posted: 13 Apr 2021 (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.

The study is to evaluate the efficacy and safety of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

To observe the PK characteristics of SHR6390 combined with endocrine therapy for the adjuvant treatment of hormone receptor positive,Human Epidermal Receptor 2 negative.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: SHR6390 Tablets compared with placebo

Arm	Type	Receives
Treatment group A	Experimental	Drug: SHR6390
Treatment group B	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Postmenopausal or premenopausal/perimenopausal female patients aged ≥18 years and ≤75 years old.
Pathological examination diagnosed as invasive breast cancer with HR+ and HER2-.
Underwent radical resection of breast cancer.
The score of ECOG was 0 - 1.
Fertile women must have a negative serum pregnancy test within 7 days before randomization, and be willing to use acceptable non hormonal contraceptive measures.

Key exclusion criteria (6 listed)

This Pathological examination diagnosed as HER2-positive breast cancer.
The history of any malignant tumor other than breast cancer within 5 years before randomization.
At the same time participate in other anti-tumor therapy clinical trials (including endocrine therapy or immunotherapy, etc.).
In the 6 months before randomization, the following conditions occurred: myocardial infarction, severe/unstable angina pectoris, , etc
Inability to swallow, intestinal obstruction, or other factors that affect the administration and absorption of the drug.

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
SHR6390SHR6390 combined with endocrine therapy	Drug	Treatment group A
placeboplacebo combined with endocrine therapy	Drug	Treatment group B

Primary outcome

IDFS（Invasive Disease-Free Survival）
Time frame: at least 5 years from the date of randomization .

5 secondary outcomes

DFS(Disease-Free Survival)
Time frame: The observation time is at least 5 years from the date of randomization . Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.
OS(Overall Survival)
Time frame: up to approximately 5 years.
DDFS(Distant Disease-Free Survival)
Time frame: from randomization to distant recurrence or death from any cause, whichever occurs first. Evaluations were conducted every 26 weeks for the first 2 years and every 52 weeks thereafter, with a follow-up of at least 5 years.
Number of Participants With adverse events (AEs) and serious adverse events (SAEs) Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0.
Time frame: up to approximately 5 years
Plasma concentration of SHR6390 will be analyzed for PK samples
Time frame: collected on day 1 of the 5th, 9th, 13th and 17th weeks, respectively.

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 1 Aug 2024.

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.

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

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 6 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 1 Aug 2024. 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. 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?

IDFS（Invasive Disease-Free Survival） (time frame: at least 5 years from the date of randomization .). 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 NCT04842617.

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 1 Aug 2024.