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Advanced Breast CancerPhase 1/2NCT03481998

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

A Phase 1/2 study testing SHR6390 and Letrozole or anastrozole or Fulvestrant in people with Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase IB/II clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Letrozole or Anastrozole or Fulvestrant. Patients who have HR positive and HER2 negative recurrent/metastatic breast cancer and have not received systemic anticancer therapy are eligible for study. 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 and Letrozole or anastrozole or Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
104 participants
Where
4 sitesChina
Study dates
22 Mar 2018to 30 Jul 2022
Phase
Phase 1/2
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, postmenopausal women.prepostmenopausal women, but should receive Ovary castration.
  • Cohort 1 and Cohort 2 :No prior systemic anti-cancer therapy for advanced HR+ disease.
  • Cohort 3 and Cohort 4 : Patients must satisfy the following criteria for prior therapy:
  • a) Progressed after 2 years during treatment of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.
  • b)Progressed within 12 months of completion of adjuvant therapy with an aromatase inhibitor if postmenopausal, or tamoxifen if pre- or perimenopausal.
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  • Progressed while 6 month after the end of prior aromatase inhibitor therapy for advanced/metastatic breast cancer if postmenopausal, or prior endocrine treatment for advanced/metastatic breast cancer if pre- or perimenopausal.
  • One previous line of chemotherapy for advanced/metastatic disease is allowed in addition to endocrine therapy.
  • 4. Eastern Cooperative Oncology Group [ECOG] 0-1 Measurable disease as per Response Evaluation Criterion in Solid Tumors[RECIST] 1.1
  • 5. Adequate organ and marrow function

Who cannot join

  • Confirmed diagnosis of HER2 positive disease
  • Patients who received any endocrine therapy as neo/adjuvant therapy for breast cancer are eligible. If the neo/adjuvant therapy of any endocrine therapy , the disease-free interval must be greater than 12 months from the completion of treatment until study entry.
  • Patients who received prior treatment with any CDK4/6 inhibitor, everolimus,fulvestant.
  • 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.
  • Has known active central nervous system metastases.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing

  • Sir Run Run Shaw Hospital of Zhejiang University

    Hangzhou, Zhejiang

  • Ha'erbin Tumor Hospital

    Harbin, Heilongjiang

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

About this study

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

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

Being tested
SHR6390, Letrozole or anastrozole or Fulvestrant
Keywords
CDK4/6 inhibitor, Breast cancer, Postmenopausal women, Hormone-receptor positive, HER2 negative, Premenopausal women
Medical subject headings
Breast Neoplasms

What participants receive

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

  • SHR6390Drug

    SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment

  • Letrozole or anastrozole or FulvestrantDrug

    Letrozole 2.5mg or anastrozole 1mg, orally once daily (continuously)， or Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease

Study groups in NCT03481998
Study groupRoleWhat they receive
Cohort 1 (Part 1)ExperimentalParticipants receive SHR6390 (at protocol defined dose levels) in combination with letrozole 2.5 mg or anastrozole 1mg, orally once daily (continuously).
Receives: Drug: SHR6390; Drug: Letrozole or anastrozole or Fulvestrant
Cohort 2 (Part 1)ExperimentalSHR6390 (TBD), in combination with letrozole 2.5 mg or anastrozole 1mg, orally once daily (continuously).
Receives: Drug: SHR6390; Drug: Letrozole or anastrozole or Fulvestrant
SHR6390 + Letrozole or anastrozole (Part 2)ExperimentalSHR6390 (RP2D, recommended Phase 2 dose), in combination with letrozole 2.5 mg or anastrozole 1mg, orally once daily (continuously).
Receives: Drug: SHR6390; Drug: Letrozole or anastrozole or Fulvestrant
SHR6390 + Fulvestrant Cohort 3 (Part 1)ExperimentalSHR6390 (at protocol defined dose levels), in combination with Fulvestrant 500 mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle once daily
Receives: Drug: SHR6390; Drug: Letrozole or anastrozole or Fulvestrant
SHR6390 + Fulvestrant Cohort 4 (Part 1)ExperimentalSHR6390 (TBD), in combination with Fulvestrant 500 mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle once daily
Receives: Drug: SHR6390; Drug: Letrozole or anastrozole or Fulvestrant

What is being measured

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

  1. Number of Participants With adverse events (AEs) and serious adverse events (SAEs) at Phase 1

    Incidence, nature, and severity of adverse events graded according to the NCI CTCAE v4.03.

    Up to 24 months.

    Measured: Up to 4 weeks

Secondary outcomes (8)

  1. Area under the plasma concentration versus time curve (AUC) of SHR6390

    Measured: Up to 4 weeks

  2. Peak Plasma Concentration (Cmax) of SHR6390

    Measured: Up to 4 weeks

  3. The time of SHR6390 to reach the maximum concentration (Tmax)

    Measured: Up to 4 weeks

  4. Half-time (t1/2) of SHR6390

    Measured: Up to 4 weeks

  5. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1

    ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ¡Ý30% decrease in the sum of diameters of target lesions) per RECIST 1.1.

    Measured: Up to approximately 24 months.

  6. 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.

  7. Disease Control Rate (DCR) per RECIST 1.1

    DCR is defined as the percentage of participants in the analysis population who have a CR, PR or SD per RECIST 1.1.

    Measured: Up to approximately 24 months.

  8. 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 v4.03.

    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 Mar 2018
  2. Study start22 Mar 2018
  3. Primary completion30 Jul 2022
  4. Study completion30 Jul 2022

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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
104 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03481998
Sponsor's protocol ID
SHR6390-Ib/II-201
Status last verified
Nov 2023
First submitted
14 Mar 2018
Last updated
21 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang Q, Zhang P, Yan M, Yan X, Wang X, Gu Y, Qu X, Li S, Xu G, Zhu X, Xu B. Dalpiciclib in combination with letrozole/anastrozole or fulvestrant in HR-positive and HER2-negative advanced breast cancer: results from a phase Ib study. Ther Adv Med Oncol. 2024 Sep 2;16:17588359241273026. doi: 10.1177/17588359241273026. eCollection 2024.

    PubMed 39229468

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SHR6390 and Letrozole or anastrozole or Fulvestrant in people with Advanced Breast Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 4 sites 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 10 inclusion and 5 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: finished, as of the sponsor's last update on 21 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Number of Participants With adverse events (AEs) and serious adverse events (SAEs) at Phase 1 (time frame: Up to 4 weeks). 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 NCT03481998, which also lists 1 linked publication.

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 21 Nov 2023.

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