Breast Neoplasm FemalePhase 2NCT05577442
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer
A Phase 2 study testing Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy in people with Breast Neoplasm Female, run by Peking University Cancer Hospital & Institute.
Trial summary
This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Breast Neoplasm Female
- What is being tested?
- Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2022to 20 Oct 2024
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female breast cancer patients of any menopausal status aged 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Female breast cancer patients with HER2-positive HR-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure.
- ER and/or PR +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and HER2 +: defined as IHC 3 + or IHC 2 + and FISH +/CISH +.
- measurable lesions by RECIST 1.1 criteria.
- Patients' previous treatment should meet: a) prior systemic (neo) adjuvant therapy is allowed but not required, and if received, the disease-free interval (DFI) must be > 24 months (DFI is defined as the time from surgery to the first recurrence); b) ≤ 1 line of systemic therapy for the tumor (including anti-HER2 targeted therapy, endocrine therapy and chemotherapy) is received at the metastatic stage;
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- Stable patients with brain metastases are allowed.
- life expectancy ≥ 12 weeks.
- adequate organ and bone marrow function.
- adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram.
Who cannot join
- patients who are not suitable for endocrine therapy as judged by the investigator. Including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates [pleural, pericardial, abdominal], pulmonary lymphangitis and more than 50% hepatic involvement).
- previous treatment with CDK4/6 inhibitors.
- previous treatment with TKI.
- visceral crisis.
- Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.
- Have been diagnosed with any other malignancy within 3 years before entering the study, except for curatively treated non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Peking University Cancer Hospital & Institute
This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.
Read the detailed description
This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib（320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.
- Conditions
- Breast Neoplasm Female
- Being tested
- Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine TherapyDrug
Also called Trastuzumab Pyrotinib Dalpiciclib
Trastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks separated by one week）
| Study group | Role | What they receive |
|---|---|---|
| Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy | Experimental | for the HR+/HER2+MBC will be treated with Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy. Endocrine drug be determined by physician depend on the history. Receives: Drug: Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Measured: 8week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start20 Oct 2022 (estimated)
- Primary completion20 Oct 2023 (estimated)
- Study completion20 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Neoplasm FemaleStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Huiping, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577442
- Sponsor's protocol ID
- OBU-BC-Ⅱ-077
- Status last verified
- Oct 2022
- First submitted
- 9 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peking University Cancer Hospital & Institute
- ClinicalTrials.gov ID
- NCT05577442
- Acronym / sponsor ID
- OBU-BC-Ⅱ-077
- Conditions
- Breast Neoplasm Female
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 20 Oct 2022 (estimated)
- Primary completion
- 20 Oct 2023 (estimated)
- Study completion
- 20 Oct 2024 (estimated)
- First posted
- 13 Oct 2022 (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.
This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.
Detailed description
This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib（320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy | Experimental | Drug: Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapyfor the HR+/HER2+MBC will be treated with Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy. Endocrine drug be determined by physician depend on the history. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Female breast cancer patients of any menopausal status aged 18-75 years.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
- Female breast cancer patients with HER2-positive HR-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure.
- ER and/or PR +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and HER2 +: defined as IHC 3 + or IHC 2 + and FISH +/CISH +.
- measurable lesions by RECIST 1.1 criteria.
Key exclusion criteria (6 listed)
- patients who are not suitable for endocrine therapy as judged by the investigator. Including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates [pleural, pericardial, abdominal], pulmonary lymphangitis and more than 50% hepatic involvement).
- previous treatment with CDK4/6 inhibitors.
- previous treatment with TKI.
- visceral crisis.
- Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.
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 |
|---|---|---|
| Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine TherapyAlso: Trastuzumab Pyrotinib DalpiciclibTrastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks separated by one week） | Drug | Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy |
Primary outcome
ORR
Time frame: 8week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy in people with Breast Neoplasm Female, run by Peking University Cancer Hospital & Institute.
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 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: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
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 GUOHONG SONG (13911263305, songguohong918@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: 8week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2022.