Neoadjuvant Treatment for HER2-positive, ER-positive Breast CancerPhase 2NCT04858516
Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in Estrogen Receptor (ER)-Positive, HER2-positive Breast Cancer
A Phase 2 study testing palbociclib and exemestane plus trastuzumab and pyrotinib in people with Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer, run by Guangdong Provincial People's Hospital.
Trial summary
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable for neoadjuvant therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer
- What is being tested?
- palbociclib and exemestane plus trastuzumab and pyrotinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- 30 Apr 2021to 30 Apr 2025
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- We judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive (3+ on immunohistochemistry or neu-amplified) and ER-positive (>10% of cells in the tumour expressing ER) breast cancer. Other inclusion criteria were age 18 years or older, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less, and tumour classified between cT1c and cT4a-d.
Who cannot join
- metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.
About this study
Official title: Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in ER-positive, HER2-positive Breast Cancer (neoPEHP): an Exploratory, Open-label, Multi-center Phase 2 Study
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable for neoadjuvant therapy. Patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po QD) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po QD) every 4 weeks for 24 weeks. The primary endpoints was pathological complete response.
- Being tested
- palbociclib and exemestane plus trastuzumab and pyrotinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
palbociclib and exemestane plus trastuzumab and pyrotinibDrug
Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib | Experimental | Not described Receives: Drug: palbociclib and exemestane plus trastuzumab and pyrotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathological complete response(ypT0/is,ypN0, pCR)
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start30 Apr 2021 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoadjuvant Treatment for HER2-positive, ER-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's HospitalThe 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
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858516
- Sponsor's protocol ID
- 20201101.2
- Status last verified
- Apr 2021
- First submitted
- 18 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in ER-positive, HER2-positive Breast Cancer (neoPEHP): an Exploratory, Open-label, Multi-center Phase 2 Study
- ClinicalTrials.gov ID
- NCT04858516
- Acronym / sponsor ID
- 20201101.2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- 30 Apr 2021 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 26 Apr 2021 (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.
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable for neoadjuvant therapy. Patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po QD) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po QD) every 4 weeks for 24 weeks. The primary endpoints was pathological complete response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib | Experimental | Drug: palbociclib and exemestane plus trastuzumab and pyrotinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- We judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive (3+ on immunohistochemistry or neu-amplified) and ER-positive (>10% of cells in the tumour expressing ER) breast cancer. Other inclusion criteria were age 18 years or older, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less, and tumour classified between cT1c and cT4a-d.
Key exclusion criteria (1 listed)
- metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.
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 |
|---|---|---|
| palbociclib and exemestane plus trastuzumab and pyrotinibNeoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer | Drug | Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib |
Primary outcome
pathological complete response(ypT0/is,ypN0, pCR)
Time frame: 24 weeks
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing palbociclib and exemestane plus trastuzumab and pyrotinib in people with Neoadjuvant Treatment for HER2-positive, ER-positive Breast Cancer, run by Guangdong Provincial People's Hospital.
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 1 inclusion and 1 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 26 Apr 2021. 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?
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?
pathological complete response(ypT0/is,ypN0, pCR) (time frame: 24 weeks). 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 26 Apr 2021.