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Breast CancerPhase 2NCT07299890

An Exploratory Study of Pertuzumab and Trastuzumab in Combination With Palbociclib and Exemestane as Neoadjuvant Therapy for Triple-Positive Breast Cancer

A Phase 2 study testing Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane in people with Breast Cancer, run by Anhui Provincial Cancer Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a prospective, multicenter, single-arm, exploratory study. A total of 90 patients with early/later-stage triple-positive breast cancer who were scheduled to receive neoadjuvant therapy were recruited. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
No sites listed yet
Study dates
20 Dec 2025to 1 Nov 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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient must meet all of the following criteria to be included in the study:
  • The tumor stage must be in accordance with the 8th edition of the AJCC standard, being stage II-III for the initial diagnosis;
  • Pre-menopausal or perimenopausal patients (if this is the case, combined with OFS, which includes bilateral oophorectomy or GnRHa drugs), or post-menopausal patients;
  • All patients must have been pathologically confirmed as HR+/HER2 receptor positive. The estrogen receptor (ER) is positive (>10%), the progesterone receptor (PR) is positive (>1%), and the HER2 receptor is positive. Follow the 2018 ASCO-CAP HER2 positive interpretation guideline standards. The immunohistochemistry (IHC) score is 3+ or 2+ and the in situ hybridization (ISH) test is positive (ISH amplification rate ≥ 2.0);
  • Age 18-75 years (inclusive of 18 and 75), female;
  • ECOG score 0-1;
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  • Expected survival time ≥ 12 weeks;
  • According to the RECIST 1.1 standard, there must be at least one measurable lesion;
  • The functional level of organs must meet the following requirements: (a) Blood routine: ANC ≥ 1.5×109/L; PLT ≥ 90×109/L; Hb ≥ 90g/L; (b) Blood biochemistry: TBIL ≤ 1.5×ULN; ALT and AST ≤ 3×ULN; BUN and Cr ≤ 1.5×ULN and creatinine clearance rate ≥ 50 mL/min; (c) Cardiac echocardiography: Left ventricular ejection fraction ≥ 50%:
  • The subject voluntarily joins this study, signs the informed consent, has good compliance and is willing to cooperate with follow-up.

Who cannot join

  • If the patient meets any of the following conditions, they will not be eligible:
  • Has received any form of anti-tumor treatment (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
  • Is concurrently receiving other anti-tumor drug treatments;
  • Stage IV breast cancer;
  • Breast cancer without pathological tissue diagnosis;
  • Has had other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;
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  • Patients with severe dysfunction of important organs such as heart, liver, and kidney;
  • Unable to swallow, chronic diarrhea and intestinal obstruction, with multiple factors affecting the administration and absorption of the drugs;
  • Participated in other drug clinical trials within 4 weeks before enrollment;
  • Has a history of immunodeficiency diseases, including positive HIV test, HCV, active viral hepatitis or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;
  • Has a known history of allergic reaction to the components of this drug regimen;
  • Has had any heart diseases, including: requiring drug treatment or clinically significant arrhythmia; myocardial infarction; heart failure; any other heart diseases judged by the researcher as unsuitable for participation in this trial;
  • Pregnant or lactating female patients, female patients with reproductive capacity and positive baseline pregnancy test results;
  • According to the investigator's judgment, there are serious accompanying diseases that endanger the patient's safety or affect the patient's completion of the study (including but not limited to severe hypertension that cannot be controlled by drugs, severe diabetes, active infection, etc.);
  • Has a clear history of neurological or mental disorders, including epilepsy or dementia;
  • The investigator considers that the patient is not suitable for participating in this study in any other circumstances.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Pan Yueyin contact

13805695539

panyueyin@ustc.edu.cn

About this study

This study is a prospective, multicenter, single-arm, exploratory study. A total of 90 patients with early/later-stage triple-positive breast cancer who were scheduled to receive neoadjuvant therapy were recruited. They received neoadjuvant treatment with trastuzumab, pertuzumab, palbociclib, and exemestane in combination. The aim of this study is to evaluate the efficacy and safety of the neoadjuvant treatment regimen of trastuzumab-pertuzumab combined with palbociclib and exemestane in triple-positive breast cancer.

Conditions
Breast Cancer
Being tested
Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Trastuzumab and Pertuzumab Combination with Palbociclib and ExemestaneDrug

    Neoadjuvant treatment regimen:

    QL1701 (Trastuzumab for Injection): First dose 8mg/kg, then 6mg/kg, every 3 weeks, for a total of 6 cycles; QL1209 (Pertuzumab Injection): First dose 840mg, then 420mg, every 3 weeks, for a total of 6 cycles; Palbociclib: 125mg/day, days 1-21, every 4 weeks, for a total of 5 cycles; Exemestane: 25mg/day, every 4 weeks, for a total of 5 cycles.

Study groups in NCT07299890
Study groupRoleWhat they receive
treatment groupExperimentalTrastuzumab and Pertuzumab Combination with Palbociclib and Exemestane
Receives: Drug: Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane

What is being measured

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

  1. tpCR rate，total physiological complex response

    After the resection of the primary tumor, microscopic examination of the breast and the ipsilateral axillary lymph nodes revealed no invasive tumor cells (ypT0/is ypN0)

    Measured: From the time of enrollment to one month after the surgery

Secondary outcomes (7)

  1. bpCR，breast physiological complex response

    After the primary tumor was removed, microscopic examination of the breast revealed no invasive tumor cells (ypT0/is)

    Measured: From the time of enrollment to one month after the surgery

  2. The proportion of patients with Miller & Payne classification (MP classification) at grades 4 to 5

    Measured: From the time of enrollment to one month after the surgery

  3. EFS，Event-free survival

    The time from the start of medication to the occurrence of any of the following events for the first time: disease progression making surgical treatment impossible, local or distant recurrence, death due to any cause, etc.

    Measured: baseline，1year，up to 2year

  4. ORR，Objective Response Rate

    The proportion of patients whose tumor volume has decreased by 30% and has remained stable for more than four weeks is referred to as the sum of complete response (CR) and partial response (PR).

    Measured: 6-12 months

  5. OS，Overall Survival

    Refers to the period from the start of medication use until death occurs due to any cause.

    Measured: baseline，1year，up to 2year

  6. adverse event

    Collect all adverse events that occurred in all subjects from the signing of the informed consent to 28 days after the cessation of medication, including clinical symptoms and abnormal vital signs, as well as abnormalities in laboratory tests. Record the clinical manifestations, severity, occurrence time, duration, treatment methods, prognosis, and determine the correlation between these events and the test drug.

    Measured: up to 2year

  7. PRO

    Outcome indicators reported by the patients，Score using the Chinese version of the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30, V3.0)

    Measured: through study completion, an average of 1 year

Timeline

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

  1. First posted23 Dec 2025
  2. Study start20 Dec 2025 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 Nov 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07299890
Sponsor's protocol ID
2025-LLYJ-0008
Status last verified
Dec 2025
First submitted
10 Dec 2025
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Trastuzumab and Pertuzumab Combination with Palbociclib and Exemestane in people with Breast Cancer, run by Anhui Provincial Cancer 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 10 inclusion and 16 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: opening soon, as of the sponsor's last update on 23 Dec 2025. 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?

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 Pan Yueyin (13805695539, panyueyin@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

tpCR rate，total physiological complex response (time frame: From the time of enrollment to one month after the surgery). 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 NCT07299890.

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 23 Dec 2025.

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