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AzTrials

Breast CancerPhase 2NCT05638594

Pyrotinib Combined With Trastuzumab, Dalpiciclib, Letrozole Versus TCbHP (Trastuzumab Plus Pertuzumab With Docetaxel and Carboplatin) as Neoadjuvant Treatment in HR +/HER2 + Breast Cancer

A Phase 2 study testing Pyrotinib, Trastuzumab and Dalpiciclib in people with Breast Cancer, run by Shengjing Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Pyrotinib, Trastuzumab and Dalpiciclib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
236 participants
Where
1 siteChina
Study dates
20 Dec 2022to 10 Dec 2027
Phase
Phase 2
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

  • Female patients aged 18 -75 ;
  • Willing to receive LHRH agonist therapy (premenopausal patients only);
  • All patients were histopathologically confirmed to be estrogen receptor (ER) -positive and HER2-positive.
  • Treatment-naïve stage II-III patients with tumor stage meeting AJCC version 8 criteria;
  • ECOG score 0-1;
  • Organ function level must meet the following requirements:
  • bone marrow function • ANC ≥ 1.5 x 109/L ; • PLT ≥ 100 × 109/L • Hb ≥ 90 g/L ; (2) hepatic and renal function • TBIL ≤ 1.5 × ULN; • AL and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastases); • BUN and Cr ≤ 1.5 × ULN and creatinine clearance ≥ 50 mL/min; (Cockcroft-Gault formula) (3) Echocardiography: LVEF ≥ 50%; (4) 12-lead ECG: QT interval ≤ 480 ms; 7. Able to undergo needle biopsy; 8. Voluntarily join this study to sign informed consent, have good compliance and willing to cooperate with follow-up.

Who cannot join

  • Received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
  • Received any other anti-tumor therapy at the same time;
  • Bilateral breast cancer, inflammatory breast cancer or occult breast cancer;
  • Stage IV breast cancer;
  • Breast cancer without histopathological diagnosis;
  • Other malignant tumors in the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;
Show all 14Show fewer
  • Severe heart, liver and kidney and other vital organ dysfunction;
  • Inability to swallow, chronic diarrhea and intestinal obstruction, there are a variety of factors affecting drug administration and absorption;
  • Participated in other drug clinical trials within 4 weeks before enrollment;
  • Known history of hypersensitivity to the drug components of this protocol; history of immunodeficiency, including positive HIV test, HCV, active viral hepatitis B or other acquired, congenital immunodeficiency diseases, or history of organ transplantation;
  • Had any cardiac disease, including: (1) cardiac arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be inappropriate for participation in this trial;
  • Female patients who are pregnant or lactating, female patients of childbearing potential with a positive baseline pregnancy test, or female patients of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
  • According to the investigator 's judgment, there are concomitant diseases that seriously jeopardize the patient' s safety or affect the patient 's completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.);
  • Had a documented history of neurological or psychiatric disorders, including epilepsy or dementia.Any other condition that, in the opinion of the investigator, would make the patient inappropriate for participation in this study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nan Niu contact

+8618940256668

niunannancy@163.com

China1 site, 1 recruiting

  • Shengjing Hospital of China Medical University

    Shenyang, Liaoning, 110004

    Cai-Gang Liu, PHD, +86 18940254967, liucg@sj-hospital.org

    Cai-Gang Liu, PHD

    Recruiting

Other trials in China

About this study

Official title: A Randomized Controlled, Open-label, Multicenter Clinical Study of Pyrotinib Maleate Combined With Trastuzumab,Dalpiciclib, and Letrozole Versus Trastuzumab Combined With Pertuzumab, Docetaxel, and Carboplatin as Neoadjuvant Therapy for Stage II-III HR +/HER2 + Breast Cancer

This is an investigator-initiated randomized controlled, open-label, multicenter, prospective Phase 2 clinical study. Patients with stage II-III HR +/HER2 + breast cancer were randomly divided into two groups at a ratio of 1:1. The experimental group received pyrotinib combined with trastuzumab, dalpiciclib and letrozole; the control group received trastuzumab combined with pertuzumab, docetaxel and carboplatin. The main study objective was to evaluate the efficacy and safety of neoadjuvant therapy for HR +/HER2 + breast cancer in the two groups.

Conditions
Breast Cancer
Being tested
Pyrotinib, Trastuzumab, Dalpiciclib, Letrozole, Pertuzumab
Medical subject headings
Breast Neoplasms

What participants receive

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

  • PyrotinibDrug

    320mg, qd

  • TrastuzumabDrug

    Also called Herceptin

    8 mg/kg first dose, then 6 mg/kg，q3w

  • DalpiciclibDrug

    125mg , qd，d1-21, q4w

  • LetrozoleDrug

    2.5mg，qd

  • PertuzumabDrug

    Also called Perjeta

    840 mg first dose, then 420 mg, q3w

  • DocetaxelDrug

    75 mg/m2, q3w

  • CarboplatinDrug

    AUC 6, q3w

  • Gonadotropin-releasing hormone agonistDrug

    Every 4 weeks for 5 cycles, premenopausal patients only

Study groups in NCT05638594
Study groupRoleWhat they receive
Pyrotinib +trastuzumab+dalpiciclib+letrozoleExperimentalEvery 4 weeks for 5 cycles. Cumulative 20 weeks of treatment. Premenopausal patients need to receive ovarian function suppression
Receives: Drug: Pyrotinib; Drug: Trastuzumab; Drug: Dalpiciclib; Drug: Letrozole; Drug: Gonadotropin-releasing hormone agonist
Trastuzumab + pertuzumab + docetaxel + carboplatinActive comparatorEvery 3 weeks for 6 cycles. Cumulative 18 weeks of treatment
Receives: Drug: Trastuzumab; Drug: Pertuzumab; Drug: Docetaxel; Drug: Carboplatin

What is being measured

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

  1. Pathologic Complete Response Rate (tpCR: ypT0-is/ypN0)

    Proportion of patients without any residual invasive cancer in pathological assessment of hematoxylin and eosin-stained resected breast cancer samples and all ipsilateral lymph node samples following completion of neoadjuvant therapy and surgery

    Measured: 3 years

Secondary outcomes (3)

  1. Best overall response

    Proportion of patients with tumor response at any time during the study

    Measured: 3 years

  2. Breast Pathologic Complete Response Rate (bpCR: ypT0-is)

    Proportion of patients without any residual invasive carcinoma in pathological assessment of hematoxylin and eosin stained resected breast cancer samples following completion of neoadjuvant therapy and surgery.

    Measured: 3 years

  3. Residual cancer burden (RCB)

    RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery

    Measured: 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 posted6 Dec 2022
  2. Study start20 Dec 2022
  3. Primary completion10 Dec 2025 (estimated)
  4. Study completion10 Dec 2027 (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
236 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05638594
Sponsor's protocol ID
MUKDEN-09
Status last verified
Mar 2023
First submitted
24 Nov 2022
Last updated
20 Mar 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Huo S, Xue J, Wang S, Shan H, Chen G, Niu N, Wang Y, Qiu F, Zhao Y, Xing F, Zheng X, Tu W, Li K, Zhao H, Tang M, Xu Q, Liu C, Zhao Y, Jiang X, Pang Z, Zhang K, Zhang D, Chen ZS, Liu C. A pilot trial of neoadjuvant pyrotinib plus trastuzumab, dalpiciclib, and letrozole for triple-positive breast cancer. MedComm (2020). 2024 Mar 10;5(3):e505. doi: 10.1002/mco2.505. eCollection 2024 Mar.

    PubMed 38469548

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pyrotinib, Trastuzumab and Dalpiciclib in people with Breast Cancer, run by Shengjing Hospital 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 7 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 20 Mar 2023. 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?

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?

Contact Nan Niu (+8618940256668, niunannancy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathologic Complete Response Rate (tpCR: ypT0-is/ypN0) (time frame: 3 years). 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 NCT05638594, 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 20 Mar 2023.

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