Neoadjuvant oral paclitaxel with subcutaneous pertuzumab and trastuzumab 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

OPTIMAL-BC is a multicenter, single-arm study using a Simon two-stage design that gives oral paclitaxel plus a fixed-dose subcutaneous combination of pertuzumab and trastuzumab every three weeks for six cycles prior to surgery. All participants undergo surgery according to local guidelines after completing neoadjuvant therapy. The primary endpoint is total pathological complete response (tpCR, ypT0/is, ypN0). Key eligibility includes adults 18 to 75 with HER2-positive invasive breast cancer (T1c–4, N0–3, M0, excluding T1cN0M0) and adequate cardiac and organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Aged 18-75 years old. Histologically confirmed HER2-positive invasive breast cancer with clinical stages T1c-4, N0-3, and M0 (excluding T1cN0M0), according to the 8th American Joint Committee on Cancer (AJCC) edition BC staging system HER2 overexpression was defined as immunohistochemistry (IHC) 3+ or 2+ with HER2 gene amplification, determined by fluorescence in situ hybridization (FISH).

Baseline left ventricular ejection fraction (LVEF) of ≥50%. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.

The functional level of major organs must meet the following requirements (no blood transfusion and no use of white blood cell, red blood cell and platelet-raising drugs within 2 weeks before the first dose):

* Absolute neutrophil count ≥ 1,500/mcL
* Platelets ≥ 100,000/mcL
* Hemoglobin ≥ 9.0 g/dL
* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤1.5×ULN
* Blood urea nitrogen and serum creatinine ≤1.5×ULN
* Creatinine clearance (Ccr) ≥50 ml/min (Cockcroft-Gault formula) Signature of informed consent

Exclusion Criteria:

* History of invasive breast cancer. Bilateral breast cancer or inflammatory breast cancer . Prior excisional and/or incisional biopsy of the primary tumor and/or axillary lymph nodes.

Prior systemic therapy for breast cancer. History of life-threatening hypersensitivity reactions or known hypersensitivity to any component of the investigational drug.

Participation in another clinical trial of a drug or medical device within 4 weeks prior to the first dose and/or receipt of investigational drug/device during the trial.

Major surgery within 28 days prior to the first dose or planned major surgery during the study period.

History of other malignancies within the past 5 years, except for carcinoma in situ of the cervix, non-melanoma skin cancer, localized prostate cancer, or ductal carcinoma in situ.

Active tuberculosis or other severe infectious diseases requiring systemic treatment, including but not limited to bacteremia, severe pneumonia, and other serious infections.

History of immunodeficiency or autoimmune diseases, including but not limited to HIV infection (HIV antibody positive), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.

History of cardiovascular or cerebrovascular diseases, including:

* Unstable angina;
* Clinically significant arrhythmias requiring medication;
* Myocardial infarction within the past 6 months;
* Heart failure or second-degree or higher atrioventricular block;
* Cerebral infarction (excluding lacunar infarction) or cerebral hemorrhage within the past 6 months.

Poorly controlled hypertension (systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg despite regular medication), or history of hypertensive crisis or hypertensive encephalopathy.

Unsuitability for oral administration of the investigational drug, as judged by the investigator, including:

* Clinically significant or uncontrolled congenital or acquired gastrointestinal diseases;
* Diseases that may affect drug administration, gastric entry, or absorption (e.g., intestinal obstruction, Crohn's disease, ulcerative colitis).

Pregnant or breastfeeding women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception during the study and for 6 months after the last dose.

Where it's running

• Sun Yat-sen Memorial Hospital
  Guangzhou, Guangdong, China Recruiting
• Peking University Cancer Hospital
  Beijing, Beijing Municipality, China Not yet recruiting
• Guangdong Women and children Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Cancer Hospital of Shantou University Medical College
  Shantou, Guangdong, China Not yet recruiting
• Guangxi Provincial Cancer Hospital
  Nanning, Guangxi, China Not yet recruiting
• The Affiliated Hospital of Guizhou Medical University
  Guiyang, Guizhou, China Not yet recruiting

Study contacts

• Principal investigator: Qiang Liu, PhD — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Qiang Liu, PhD
• Email: liuqiang_sysu@163.com
• Phone: 86-13922251256

Similar studies

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

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  This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.

  Recruiting Phase 3 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07797218

• Olaparib with Trastuzumab and Pertuzumab before surgery for older women with HER2-positive breast cancer

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  Recruiting Phase 4 Zhejiang Cancer Hospital · Hangzhou, Zhejiang · NCT07695259

• Paclitaxel micelles with HER2-targeted therapy vs standard taxane-based therapy as first-line treatment for advanced HER2-positive breast cancer

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• Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer

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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.