HER2-positive Breast CancerNCT06035016
Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
An observational study of HER2-positive Breast Cancer and Early-stage Breast Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HER2-positive Breast Cancer, Early-stage Breast Cancer
- What is being tested?
- pyrotinib combined with Capecitabine and treatment of physician's choice
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Jun 2027
- Phase
- Observational
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
Study population: HER2 positive early-stage breast cancer patients expected to receive adjuvant treatment
Who may be able to join
- Female patients ≥ 18 years and ≤ 75 years old;
- Primary invasive breast cancer confirmed by histology;
- HER2 positive breast cancer (IHC 3+, or IHC 2+ and FISH positive); lymph node positive, except for T0; lymph node negative and tumor >1cm, or tumor > 0.5 cm and ≤ 1cm, and accompanied by any of the following high-risk factors: pathological grade 3, ER/PR negative, or < 35 years old;
- Having received mastectomy or breast conserving surgery, and received sentinel lymph node biopsy or axillary lymph node dissection, and within 90 days from the breast surgery;
- With known ER/PR status of breast cancer;
- ECOG score 0-1;
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- The patient's major organ functions meet all of the following requirements for blood tests:
- Neutrophil count (ANC) ≥ 1,500/mm3 (1.5×109/L);
- Platelet count (PLT) ≥ 75,000/mm3 (75×109/L);
- Hemoglobin (Hb) ≥ 8 g/dL (80 g/L);
- Serum creatinine (SCr) ≤ 1.5 times the upper limit of normal (ULN) or creatinine clearance ≥ 60 mL/min;
- Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN);
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level ≤ 2.5 times the upper limit of normal (ULN), patients with liver metastases should be ≤ 5×ULN.
- 9. The participant voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-ups.
Who cannot join
- Breast cancer recurs before enrollment, or local recurrence/ metastasis confirmed by radiology;
- The subject has participated in other clinical trials within 4 weeks or 5 half-lives (whichever is longer) before enrollment;
- The patient has previously received treatment including tyrosine kinase inhibitors targeting HER2 (e.g., lapatinib, neratinib, and pyrotinib);
- The patient has been diagnosed with other malignancies within 5 years of enrollment, except for cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin which has been cured;
- The patient is receiving anti-tumor therapies from other clinical trials;
- Inability to swallow, chronic diarrhea, or intestinal obstruction, with multiple factors affecting drug administration and absorption;
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- The patient has undergone major surgical procedures unrelated to breast cancer within 4 weeks of enrollment, or has not fully recovered from such surgical procedures;
- With known allergies to any components of the agents to be administered in this study; history of acquired or congenital immunodeficiency diseases, including HIV; history of HCV, active hepatitis B, or history of organ transplantation;
- Pregnant and lactating patients, patients of fertility unwilling to take effective contraceptive measures throughout the trial;
- With any heart disease including: (1) arrhythmia requiring medication or clinical attention; (2) myocardial infarction; (3) heart failure; (4) any other heart diseases that are considered unsuitable to the trial;
- With any comorbidities that are considered to potentially endanger the patient's safety or interfere with the study, including but not restricted to resistant hypertension, severe diabetes, active infection, etc.;
- With a history of neurological or mental disorders, including but not restricted to epilepsy or dementia;
- The patient is using CYP3A4 inhibitors or inducers, or any other drugs that potentially prolong the QT interval;
- Any other circumstances in which the researcher believes that the patient is not suitable 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
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Xuefei Wang, Dr., 861069158720, 1210548954@qq.com
About this study
Official title: A Prospective, Multicenter and Registry-based Cohort Study of Pyrotinib Plus Capecitabine for Adjuvant Treatment of HER2 Positive Early-stage Breast Cancer
This is a prospective, multicenter, registry-based cohort study to explore the efficacy and safety of Pyrotinib combined with Capecitabine for adjuvant treatment of HER2 positive early breast cancer compared with treatment of physician's choice. Pyrotinib is a small molecule tyrosine kinase inhibitor which can irreversibly inhibit HER1, HER2, and HER4.
- Being tested
- pyrotinib combined with Capecitabine, treatment of physician's choice
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pyrotinib combined with CapecitabineDrug
Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w
treatment of physician's choiceDrug
Treatment of physician's choice
| Study group | Role | What they receive |
|---|---|---|
| cohort A | Pyrotinib 400mg, qd, po, day 1-21, q3w, Capecitabine 1000mg/m2, bid po d1-14, q3w Receives: Drug: pyrotinib combined with Capecitabine | |
| cohort B | treatment of physician's choice Receives: Drug: treatment of physician's choice |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year IDFS
The 3-year IDFS (invasive disease-free survival) is defined as the time from the date of enrollment to the first occurrence of recurrent diseases. Recurrent diseases include ipsilateral or contralateral recurrent breast cancer, local or regional recurrence, remote recurrence and death caused by any reason. The observation period is from enrollment to 3 years after enrollment.
Measured: 3 Year
Secondary outcomes (2)
AEs and SAEs
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs) are recorded according to the NCI CTCAE v5.0.
Measured: 3 Year
QoL
The quality of life (QoL) of the participants is assessed according to the EORTC QLQ-C30 quality of life questionnaire.
Measured: 3 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Jun 2023
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qiang SUN, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035016
- Sponsor's protocol ID
- aPC-BC
- Status last verified
- Sep 2023
- First submitted
- 6 Sep 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided