Breast CancerPhase 2NCT06276868
Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer
A Phase 2 study testing Dalcilib+letrozole+HP treatment group in people with Breast Cancer and HER2-positive Breast Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer
- What is being tested?
- Dalcilib+letrozole+HP treatment group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2024to 1 Jun 2029
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years.
- ECOG score 0-1 points.
- Pathologically confirmed as invasive breast cancer, with tumor staging of II-IIIA.
- HR positive HER-2 positive.
- The main organs function normally and meet the following standards:
- （1）The blood routine examination standards must comply with:ANC ≥1.5×10 9/L；PLT ≥100×109/L；Hb ≥90g/L. （2）Biochemical examination must meet the following standards: TBIL ≤ 1.5 Upper limit of normal value (ULN)；ALT and AST ≤ 1.5 times the upper limit of normal value (ULN)；Alkaline phosphatase ≤ 2.5 times the upper limit of normal value (ULN)；BUN and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min； （3）Cardiac ultrasound and echocardiography: Left ventricular ejection fraction (LVEF ≥ 50%).
- 6. For female patients who have not undergone menopause or surgical sterilization: Agree to abstain or use effective contraceptive methods during the treatment period and at least 7 months after the last administration during the study treatment.
- 7. Volunteer to join this study and sign an informed consent form.
Who cannot join
- Stage IV (metastatic) breast cancer.
- inflammatory breast cancer.
- Previously received anti-tumor therapy or radiation therapy for any malignant tumor, excluding cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
- Individuals who have previously suffered from clinically significant lung diseases, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonia (excluding radiation changes that do not require corrective treatment), or those who have been found to have such diseases through screening period examinations.
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- Serious heart disease or discomfort, including but not limited to the following diseases:
- （1）Confirmed history of heart failure or systolic dysfunction (LVEF<50%). （2）High risk uncontrolled arrhythmia（atrial tachycardia，ventricular tachycardia，Higher level atrioventricular block）； （3）Angina pectoris requiring treatment with anti angina drugs； （4）Clinically significant heart valve disease； （5）ECG shows transmural myocardial infarction； （6）Poor control of hypertension (systolic blood pressure>180 mmHg and/or diastolic blood pressure>100 mmHg)； 8. Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption.
- 9. Individuals with a known history of allergies to the drug components of this protocol；Having a history of immunodeficiency, including HIV testing positive, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
- 10. Pregnant and lactating female patients, those with fertility and positive baseline pregnancy test results, or those of childbearing age who are unwilling to take effective contraceptive measures during the entire trial period and within 7 months after the last study medication.
- 11. Suffering from severe comorbidities or other comorbidities that may interfere with the planned treatment, or any other situation where the researcher deems the patient unsuitable to participate 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.
China1 site, 1 recruiting
- Recruiting
Henan cacer hospital
Henan, Henan, 450008
Zhen Liu, 13838308034
About this study
Official title: A Clinical Study of Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR Positive HER2 Positive Breast Cancer
This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
Read the detailed description
This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
All participants received 150mg of darcilib once a day. Take it continuously for 21 days, then stop taking it for 7 days, with a treatment cycle of 28 days.Letrozole 2.5mg once daily (premenopausal patients treated with OFS).Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Patuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks, with all patients receiving 8 cycles of treatment. After starting treatment and before surgery, subjects will be monitored through breast MRI to evaluate clinical tumor remission. The primary endpoint was the pCR rate in the group receiving darcilib+letrozole+HP treatment, defined as the proportion of patients who achieved pCR after surgery after neoadjuvant therapy.
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Being tested
- Dalcilib+letrozole+HP treatment group
- Keywords
- HER2-positive Breast Cancer, pathologic complete response, Dalcelli, objective response rate, Disease-free survival
- Medical subject headings
- Breast Neoplasms, Pathologic Complete Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalcilib+letrozole+HP treatment groupDrug
Also called experimental group
All participants received 150mg of darcilib once a day. Take it continuously for 21 days, then stop taking it for 7 days, with a treatment cycle of 28 days.
Letrozole 2.5mg once daily (premenopausal patients treated with OFS); Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Patuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Dalcilib+letrozole+HP | Experimental | All subjects received Dalcilib 150mg qd, stopped for 1 week after 3 weeks，and letrozole (2.5mg qd) (premenopausal combined with OFS). The subjects received 2 cycles of preoperative treatment with darcilib combined with letrozole, trastuzumab, and patstuzumab.
Then, MRI efficacy evaluation will be conducted, and patients who achieved PR continue to receive the original treatment regimen for 6 cycles, while those who did not achieve PR switched to the TCHP chemotherapy regimen for 6 cycles. Receives: Drug: Dalcilib+letrozole+HP treatment group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pathologic complete response
The proportion of patients in this group who achieved pCR after surgery after neoadjuvant therapy
Measured: Immediately after surgery
Secondary outcomes (6)
Adverse event occurrence
The incidence and severity of adverse events (including serious adverse events)
Measured: At the end of one Cycle (each cycle is 28 days)
objective response rate
The proportion of patients who achieved CR or PR before surgery after neoadjuvant therapy among all subjects
Measured: At the end of Cycle 6 (each cycle is 28 days)
Residual cancer burden
Proportion of patients with residual cancer burden score of 0-1 after surgery
Measured: Immediately after surgery
Event free survival
The time interval between enrollment and the first recording of related events, including preoperative disease progression, postoperative disease recurrence, and death from any cause.
Measured: 5 years after surgery
Disease free survival
The time interval between the first day without disease (surgery date) and the first recording of related events, including postoperative disease recurrence and death from any cause.
Measured: 5 years after surgery
Distant disease/recurrence free survival
The time interval between the first day without disease ( surgery date) and the first occurrence of distant recurrence.
Measured: 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start20 Jan 2024
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Model description
- Prospective, single arm clinical study
- Masking
- None (open label)
- Enrolment
- 71 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Zhenzhen Liu, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276868
- Sponsor's protocol ID
- HELEN-017
- Status last verified
- Nov 2024
- First submitted
- 14 Nov 2023
- Last updated
- 17 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR Positive HER2 Positive Breast Cancer
- ClinicalTrials.gov ID
- NCT06276868
- Acronym / sponsor ID
- HELEN-017
- Conditions
- Breast Cancer, HER2-positive Breast Cancer
- Keywords
- HER2-positive Breast Cancer, pathologic complete response, Dalcelli, objective response rate, Disease-free survival
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 71 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 26 Feb 2024 (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 is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
Detailed description
This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
All participants received 150mg of darcilib once a day. Take it continuously for 21 days, then stop taking it for 7 days, with a treatment cycle of 28 days.Letrozole 2.5mg once daily (premenopausal patients treated with OFS).Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Patuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks, with all patients receiving 8 cycles of treatment. After starting treatment and before surgery, subjects will be monitored through breast MRI to evaluate clinical tumor remission. The primary endpoint was the pCR rate in the group receiving darcilib+letrozole+HP treatment, defined as the proportion of patients who achieved pCR after surgery after neoadjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single arm clinical study
| Arm | Type | Receives |
|---|---|---|
| Dalcilib+letrozole+HP | Experimental | Drug: Dalcilib+letrozole+HP treatment groupAll subjects received Dalcilib 150mg qd, stopped for 1 week after 3 weeks，and letrozole (2.5mg qd) (premenopausal combined with OFS). The subjects received 2 cycles of preoperative treatment with darcilib combined with letrozole, trastuzumab, and patstuzumab. Then, MRI efficacy evaluation will be conducted, and patients who achieved PR continue to receive the original treatment regimen for 6 cycles, while those who did not achieve PR switched to the TCHP chemotherapy regimen for 6 cycles. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female initial treatment patients aged ≥ 18 years and ≤ 70 years.
- ECOG score 0-1 points.
- Pathologically confirmed as invasive breast cancer, with tumor staging of II-IIIA.
- HR positive HER-2 positive.
- The main organs function normally and meet the following standards:
Key exclusion criteria (11 listed)
- Stage IV (metastatic) breast cancer.
- inflammatory breast cancer.
- Previously received anti-tumor therapy or radiation therapy for any malignant tumor, excluding cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma.
- Simultaneously receiving anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphate therapy, or immunotherapy.
- The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before enrollment, or the patient has not fully recovered from such surgical procedures.
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 |
|---|---|---|
| Dalcilib+letrozole+HP treatment groupAlso: experimental groupAll participants received 150mg of darcilib once a day. Take it continuously for 21 days, then stop taking it for 7 days, with a treatment cycle of 28 days. Letrozole 2.5mg once daily (premenopausal patients treated with OFS); Trastuzumab (8mg/kg first dose, 6mg/kg sequential) and Patuzumab (840mg first dose, 420mg/kg sequential) were administered intravenously every 3 weeks, or fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (1200 mg pertuzumab plus 600 mg trastuzumab loading dose in 15 mL, followed by 600 mg pertuzumab plus 600 mg trastuzumab maintenance doses in 10 mL), both administered every 3 weeks. | Drug | Dalcilib+letrozole+HP |
Primary outcome
pathologic complete response
Time frame: Immediately after surgery
The proportion of patients in this group who achieved pCR after surgery after neoadjuvant therapy
6 secondary outcomes
Adverse event occurrence
Time frame: At the end of one Cycle (each cycle is 28 days)
objective response rate
Time frame: At the end of Cycle 6 (each cycle is 28 days)
Residual cancer burden
Time frame: Immediately after surgery
Event free survival
Time frame: 5 years after surgery
Disease free survival
Time frame: 5 years after surgery
Distant disease/recurrence free survival
Time frame: 5 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2024.
- Individual participant dataSharing planned: No
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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.
Zhenzhen Liu principal investigator
Henan Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalcilib+letrozole+HP treatment group in people with Breast Cancer and HER2-positive Breast Cancer, run by Henan Cancer 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 8 inclusion and 11 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 17 Dec 2024. 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 Zhenzhen Liu (0371-65587005, liuzhenzhen73@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pathologic complete response (time frame: Immediately after surgery). 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 17 Dec 2024.