Combining trastuzumab with pyrrolidine and chemotherapy for HER2-positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label phase II clinical study focusing on patients with locally advanced, inflammatory, or early HER2-positive breast cancer. Participants will receive a combination of trastuzumab, pyrrolidine, and chemotherapy over six cycles, followed by surgical intervention based on individual conditions. The primary goal is to evaluate the pathological complete response rate (pCR) in these patients. After surgery, adjuvant therapy with trastuzumab or trastuzumab plus pertuzumab will continue for up to one year, depending on the patient's needs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female between 18 and 70 years old;
2. Histologically confirmed as invasive breast cancer;
3. ECOG PS 0-1;
4. The expected survival time is not less than 12 weeks;
5. Standard immunohistochemical HER2-positive breast cancer patients (IHC +++ or FISH amplification);
6. The status of hormone receptors (ER and PR) can be known.
7. Clinical examination or imaging examination of primary lesion \>2cm;
8. Patients who are operable (T2-3, N0-1, M0), locally advanced (T2-3,N2-3, M0 or T4A-C, any N, M0) or inflammatory breast cancer (T4d, any N, M0) and who have not received any previous anti-tumor therapy (including radiotherapy, chemotherapy, targeted therapy, except those who have received bisphosphonate therapy previously);
9. Echocardiography indicated left ventricular ejection fraction (LVEF)≥55%;
10. Adequate organ and bone marrow function, as defined below: a. Neutrophil count (ANC)≥ 1,500/mm3 (1.5 × 109/L); B. Platelet count (PLT)≥ 100,000/mm3(100 × 109/L); C. Hemoglobin (Hb)≥ 9 g/dL(90 g/L); D. Serum creatinine ≤ 1.5 times upper limit of normal value (ULN) or creatinine clearance ≥ 60 ml/min(based on Cockroft - Gault formula); E. Total bilirubin (BIL)≤ 1.5 times the upper limit of normal value (ULN); F. AST/SGOT or ALT/SGPT ≤ 2.5 times upper limit of normal value (ULN);G. Urinary protein \<2+; If urinary protein ≥2+, 24-hour urinary protein quantification shows protein must1 g or less;
11. I have agreed and signed the informed consent, and am willing and able to comply with the planned visit, research treatment, laboratory examination and other test procedures.

Exclusion Criteria:

1. Have received any previous anti-tumor treatment for primary invasive breast cancer;
2. Previous (\<10 years) or other malignant tumors, except for curable cancer species: a. basal cell carcinoma of skin and squamous cell carcinoma b. Carcinoma in situ of cervix
3. For patients with other malignancies, they can also be included in the study if the time from diagnosis to enrollment exceeds 10 years; Prior surgical treatment is permitted except for radiotherapy or systemic therapy (chemotherapy or endocrine therapy);
4. Metastatic breast cancer (M1), bilateral or ipsilateral multifocal breast cancer;
5. Uncontrolled hypertension, systolic blood pressure \> 150 MMHG and/or diastolic blood pressure \> 100 MMHG), or clinical symptomatic cardiovascular disease, myocardial ischemia and myocardial infarction, severe/unstable angina, poor control of cardiac arrhythmias (including women according to Bazett formula correction QTc interphase \< 470 ms), symptoms of congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic cerebral embolism), NYHA Ⅱ magnitude cardiac insufficiency;
6. Receive other anti-tumor treatments within 4 weeks before enrollment;
7. Inability to swallow, intestinal obstruction or other factors affecting the use and absorption of medication;
8. Persons with allergic constitution or known history of allergy to the drug components of the program;
9. The patient has a severe concomitant disease or other conditions that the researcher considers inappropriate for the patient to participate in the studyIn any case;
10. Non-surgically sterilized female patients of childbearing age must have negative serum or urine HCG tests within 14 days prior to study inclusion; And must be non-lactation
11. Other circumstances deemed inappropriate for inclusion by the researcher.

Where it's running

• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Tao Ouyang, MD
• Email: ouyanghongtao@263.net
• Phone: 88271119-5002

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure

  This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.

  Recruiting Phase 1/2 Tianjin Medical University Cancer Institute and Hospital · Tianjin, Tianjin Municipality · NCT07708194

• GQ1005 versus T-DM1 in HER2-positive unresectable or metastatic breast cancer

  This trial tests whether GQ1005 works as well as T-DM1 for adults with HER2-positive unresectable or metastatic breast cancer who have already had trastuzumab and taxane.

  Recruiting at 70 sites Phase 3 GeneQuantum Healthcare (Suzhou) Co., Ltd. · Bengbu, Anhui and 69 other locations · NCT07673029

• Trastuzumab Rezetecan Neoadjuvant Therapy for HER2-Positive Breast Cancer

  This trial tests whether adding trastuzumab rezetecan after an initial THP treatment helps patients with HER2-positive breast cancer decide if they should switch therapies based on response.

  Recruiting Phase 2 The First Affiliated Hospital of Soochow University · Suzhou, Jiangsu · NCT07647263

• Pyrotinib plus trastuzumab and chemotherapy for HER2-positive early breast cancer

  This study tests a treatment combination of Pyrotinib, Trastuzumab and chemo given before surgery to see if it can improve responses in HER2-positive breast cancer patients who have not yet been treated.

  Recruiting Phase 2 Hebei Medical University Fourth Hospital · Shijiazhuang, Hebei · NCT07635342

• BL-M07D1 plus pertuzumab vs standard therapy in first-line HER2-positive breast cancer

  A Phase 3 trial tests whether adding BL-M07D1 to pertuzumab is as good as or better than docetaxel plus trastuzumab and pertuzumab in patients with newly diagnosed, unresectable or metastatic HER2-positive breast cancer.

  Recruiting at 2 sites Phase 3 Sichuan Baili Pharmaceutical Co., Ltd. · Guangzhou, Guangdong and 1 other locations · NCT07518173

• RO7771950 versus tucatinib with trastuzumab and capecitabine for HER2-positive locally advanced or metastatic breast cancer

  This test will see if RO7771950 combined with trastuzumab and capecitabine works better than tucatinib combined with the same drugs for people with HER2-positive locally advanced or metastatic breast cancer.

  Recruiting at 219 sites Phase 2/3 Hoffmann-La Roche · Huntsville, Alabama and 218 other locations · NCT07413939

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.