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Advanced Breast CancerPhase 3NCT03966898

A Study of SHR6390 in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer

A Phase 3 study testing SHR6390 Tablets and Letrozole or Anastrozole Tablets in people with Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Advanced Breast Cancer
What is being tested?
SHR6390 Tablets and Letrozole or Anastrozole Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
426 participants
Where
1 siteChina
Study dates
19 Jul 2019to 30 Dec 2023
Phase
Phase 3
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 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has the pathologically-confirmed diagnosis of locally recurrent or metastatic, hormone-receptor positive, HER2 negative Breast Cancer.
  • Age: 18 - 75 years old
  • No prior systemic anti-cancer therapy for advanced HR+ disease.
  • Eastern Cooperative Oncology Group [ECOG] 0-1

Who cannot join

  • Patients who received prior treatment with any CDK4/6 inhibitor.
  • Clinically significant cardiovascular and cerebrovascular diseases, including but not limited to severe acute myocardial infarction within 6 months before enrollment, unstable or severe angina, Congestive heart failure (New York heart association (NYHA) class > 2), or ventricular arrhythmia which need medical intervention.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Nayima Bayaxi

    Shanghai

Other trials in China

About this study

Official title: A Phase III Study to Evaluate Efficacy and Safety of SHR6390 in Combination With Letrozole or Anastrozole Versus Placebo in Combination With Letrozole or Anastrozole in Patients With HR Positive and HER2 Negative Recurrent/Metastatic Breast Cancer

This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for this study.

Being tested
SHR6390 Tablets, Placebo Tablets, Letrozole or Anastrozole Tablets

What participants receive

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

  • SHR6390 TabletsDrug

    SHR6390 Tablets

  • Placebo TabletsDrug

    Placebo Tablets

  • Letrozole or Anastrozole TabletsDrug

    Letrozole or Anastrozole Tablets

Study groups in NCT03966898
Study groupRoleWhat they receive
SHR6390, Letrozole or AnastrozoleExperimentalSHR6390, Letrozole or Anastrozole
Receives: Drug: SHR6390 Tablets; Drug: Letrozole or Anastrozole Tablets
Placebo, Letrozole or AnastrozolePlacebo comparatorPlacebo, Letrozole or Anastrozole
Receives: Drug: Placebo Tablets; Drug: Letrozole or Anastrozole Tablets

What is being measured

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

  1. Investigator-assessed PFS

    Investigator-assessed Progression Free Survival

    Measured: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, Up to approximately 24 months.

Secondary outcomes (6)

  1. Progression-free Survival (PFS) per RECIST 1.1

    PFS is defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on blinded independent central review or death due to any cause, whichever occurs first.

    Measured: Up to approximately 24 months

  2. OS

    Overall Survival

    Measured: up to 2 years

  3. ORR

    Objective Response Rate

    Measured: Up to approximately 24 months

  4. DoR

    Duration of Objective Response

    Measured: Up to approximately 24 months

  5. CBR

    Clinical Benefit rate

    Measured: Up to approximately 24 months

  6. 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

    Number of Participants With adverse events and serious adverse events Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v5.0

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted29 May 2019
  2. Study start19 Jul 2019
  3. Primary completion30 Dec 2022 (estimated)
  4. Study completion30 Dec 2023 (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
Model description
SHR6390 in combination with Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
426 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03966898
Sponsor's protocol ID
SHR6390-III-302
Status last verified
Jun 2020
First submitted
21 May 2019
Last updated
2 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hong J, Chen T, Ouyang L, Du N, Li A, Zhou Z, Zhang H, Xia Z, Meng J. Cost-effectiveness comparison of dalpiciclib and abemaciclib combined with an aromatase inhibitor as first-line treatment for HR+/HER2- advanced breast cancer. Expert Rev Pharmacoecon Outcomes Res. 2024 Apr;24(4):559-566. doi: 10.1080/14737167.2024.2330542. Epub 2024 Mar 20.

    PubMed 38470447

  • Zhang P, Zhang Q, Tong Z, Sun T, Li W, Ouyang Q, Hu X, Cheng Y, Yan M, Pan Y, Teng Y, Yan X, Wang Y, Xie W, Zeng X, Wang X, Hu C, Geng C, Zhang H, Li W, Wu X, Zhong J, Xu J, Shi Y, Wei W, Bayaxi N, Zhu X, Xu B. Dalpiciclib plus letrozole or anastrozole versus placebo plus letrozole or anastrozole as first-line treatment in patients with hormone receptor-positive, HER2-negative advanced breast cancer (DAWNA-2): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2023 Jun;24(6):646-657. doi: 10.1016/S1470-2045(23)00172-9. Epub 2023 May 11.

    PubMed 37182538

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR6390 Tablets and Letrozole or Anastrozole Tablets in people with Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. 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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 2 Jun 2021. 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?

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?

Investigator-assessed PFS (time frame: Every 8 weeks from date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, Up to approximately 24 months.). 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 NCT03966898, which also lists 2 linked publications.

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 2 Jun 2021.

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