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Metastatic Breast CancerPhase 2INPHASENCT04095390

A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer

A Phase 2 study testing Pyrotinib, SHR6390 and Letrozole in people with Metastatic Breast Cancer and HER2-positive Breast Cancer, run by Jinming Yu 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 The sponsor has not verified this record for over two years, so it may be out of date.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

The study is being conducted to evaluate the efficacy, safety and tolerability of pyrotinib combination with CDK4/6 Inhibitor SHR6390 in advanced HER2-Positive breast cancer patients who prior trastuzumab-treated. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
What is being tested?
Pyrotinib, SHR6390 and Letrozole
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
30 Sep 2019to 30 Aug 2022
Phase
Phase 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 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Metastatic HER2-Positive breast cancer prior trastuzumab-treated;
  • 18-70 Years, female;
  • HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline IHC 3+ or IHC 2+ and FISH, SISH or CISH+);
  • Status of hormone receptor is known, Estrogen receptor(ER) or Progesterone receptor(PR) positive is defined as the percentage of cells positive for ER or PR expression ≥ 10%;
  • ECOG performance status 0 or 1;
  • Life expectancy is not less than 12 weeks;
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  • At least one measurable lesion according to RECIST 1.1;
  • Patients treated with systemic treatment for advanced / metastatic breast cancer≤1 line;
  • Natural postmenopausal or OFS in Arm A;
  • Adequate function of major organs meets the following requirements (no blood components have been used within 7 days and cell growth factors have been used within 14 days before randomization):
  • Neutrophils ≥ 1.5×10^9/L
  • Platelets ≥ 100×10^9/L
  • Hemoglobin ≥ 90g/L
  • Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
  • ALT and AST ≤ 2.5 × ULN (ALT and AST≤5×ULN if liver metastasis)
  • BUN and Cr ≤ 1.5 × ULN
  • Left ventricular ejection fraction (LVEF) ≥ 50%
  • QTcF ≤ 470 ms

Who cannot join

  • Patients with central nervous system metastasis (Excluding asymptomatic brain metastases or CNS metastases stable by local treatment);
  • Unable to swallow, chronic diarrhea and intestinal obstruction, gastrointestinal absorption disorders that interfere with drug absorption;
  • Patients who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period;
  • Participated in other drug clinical trials within 4 weeks before admission;
  • Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past;
  • Previously received any CDK4/6 inhibitor treatment;
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  • Previously received Capecitabine in HR- patients;
  • Patients with other malignant tumors within 5 years or at the same time( except for cured skin basal cell carcinoma and cervical carcinoma in situ);
  • Patients receive any anti-tumor treatments other than the regimen;
  • Have a history of allergies to the drug components of this regimen,; history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation;
  • Have severe heart disease;
  • According to the judgement of the researchers, any serious coexisting disease might be harmful to the patient's safety or avoid the patients from accomplishing the treatment(e.g serious hypertension, diabetes, thyroid dysfunction,active infection etc.);
  • Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
  • History of neurological or psychiatric disorders, including epilepsy or dementia;
  • Any other situation evaluated by researchers.

Trial locations and contacts

1 site in 1 country.

Jinming Yu, MD contact

+8613806406293

jn7984729@public.jn.sd.cn

Yongsheng Wang, MD contact

+8613505409989

wangysh2008@aliyun.com

China1 site, 1 recruiting

  • Breast Cancer Center, Shandong Cancer Hospital Affiliated to Shandong University

    Jinan, 250117

    Jinming Yu, +8613806406293, jn7984729@public.jn.sd.cn

    Yongsheng Wang, +8613505409989, wangysh2008@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Phase Ⅱ Trial Program Exploring The Integration Of Novel HER2-targeted Tyrosine Kinase Inhibitor Pyrotinib and CDK4/6 Inhibitor SHR6390 Into Current Chemotherapy/Endocrine Therapy Regimes For Prior Trastuzumab-treated Advanced HER2-positive Breast Cancer

The study is being conducted to evaluate the efficacy, safety and tolerability of pyrotinib combination with CDK4/6 Inhibitor SHR6390 in advanced HER2-Positive breast cancer patients who prior trastuzumab-treated.

Being tested
Pyrotinib, SHR6390, Letrozole, Capecitabine
Medical subject headings
Breast Neoplasms

What participants receive

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

Study groups in NCT04095390
Study groupRoleWhat they receive
Arm AExperimentalHormone receptor positive,HER2 positive participants will receive Pyrotinib in combination with CDK4/6 Inhibitor SHR6390 plus Letrozole until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Receives: Drug: Pyrotinib; Drug: SHR6390; Drug: Letrozole
Arm BExperimentalHormone receptor negative,HER2 positive participants will receive Pyrotinib in combination with CDK4/6 Inhibitor SHR6390 plus Capecitabine until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Receives: Drug: Pyrotinib; Drug: SHR6390; Drug: Capecitabine
Arm CExperimentalHormone receptor negative,HER2 positive participants will receive Pyrotinib in combination with CDK4/6 Inhibitor SHR6390 until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Receives: Drug: Pyrotinib; Drug: SHR6390

What is being measured

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

  1. Objective Overall Response Rate (ORR)

    ORR was defined as percentage of participants with best (confirmed) overall response (BOR) of either CR or PR. ORR was assessed by the investigator according to RECIST version 1.1 and is based on BOR, which is defined as best response recorded from start of study treatment until disease progression/recurrence or death. Participants needed to have two consecutive assessments of PR or CR to be a responder. Only participants with measurable disease at baseline were included in the analysis of BOR and who did not have any evaluable post-baseline assessments were classified as not evaluable.

    The ORR will be reported by percentage with each arms and appropriate confidence intervals.

    Measured: 2 months

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS was defined as the time from randomization to first documented disease progression (PD) using Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) or death from any cause, whichever occurred first.

    Measured: Up to 3 years

  2. Overall Survival (OS)

    Overall Survival (OS), defined as the time from the date of randomization to the date of death, regardless of the cause of death. Participants who were alive at the time of the analysis were censored at the date of the last follow-up assessment. Participants without follow-up assessment were censored at the day of last study medication and participants with no post-baseline information were censored at the date of randomization.

    Measured: Up to 3 years

  3. Survival Rate

    Survival rate was defined as the time from randomization to 12month, the rate of participants who were alive at the time in total.

    Measured: 12 months

  4. Clinical Benefit Response (CBR)

    CBR is percentage of participants with best (confirmed) PR or CR or SD for at least 6 months. PR or CR or SD is according to RECIST version 1.1.

    Measured: 2 months

  5. Adverse Events (AEs)

    AEs were graded according to the National Cancer Institute's Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0.

    In general, AEs are graded according to the following: Grade 1 Mild AE Grade 2 Moderate AE Grade 3 Severe AE Grade 4 Life-threatening or disabling AE Grade 5 Death related to AE.

    The type, grade and frequency of AEs will be reported.

    Measured: Up to 3 years

Timeline

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

  1. First posted19 Sep 2019
  2. Study start30 Sep 2019 (estimated)
  3. Primary completion30 Nov 2021 (estimated)
  4. Study completion30 Aug 2022 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04095390
Sponsor's protocol ID
HR-BLTN-010
Acronym
INPHASE
Status last verified
Sep 2019
First submitted
16 Sep 2019
Last updated
19 Sep 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib, SHR6390 and Letrozole in people with Metastatic Breast Cancer and HER2-positive Breast Cancer, run by Jinming Yu 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 18 inclusion and 15 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 19 Sep 2019. 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 phase mean?

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinming Yu, MD (+8613806406293, jn7984729@public.jn.sd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Overall Response Rate (ORR) (time frame: 2 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 NCT04095390.

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 19 Sep 2019.

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