Neoadjuvant treatment for HER2-positive breast cancer without chemotherapy

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 phase 1b study evaluates the safety and feasibility of a neoadjuvant treatment regimen combining tucatinib, trastuzumab, and pertuzumab for patients with stage II-III HER2-positive breast cancer. The study aims to identify patients who can be effectively treated without chemotherapy, thereby reducing the associated toxicities. By utilizing DCE-MRI to select optimal responders, the study seeks to enhance the proportion of patients who can achieve a high pathological complete response. The focus is on assessing both the safety and efficacy of this targeted therapy approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Signed written informed consent
2. Histologically confirmed primary invasive breast cancer
3. Stage II - IIIA primary breast cancer according to TNM-staging (8th edition, AJCC); (largest tumor diameter on DCE-MRI ≥ 2cm (cT2-3) and/or cN1-2 confirmed with FNA or histology)
4. HER2 overexpression defined as circumferential membrane staining that is complete, intense and in \>10% of invasive tumor cells (IHC 3+) on pre-treatment biopsy
5. Known estrogen- and progesterone-receptor expression of the invasive tumor

   a. ER-negative or PR-negative is defined as \<10% of invasive tumor cell nuclei are immunoreactive in the presence of evidence that the sample can express ER and/or PR
6. WHO performance status 0-1
7. Age ≥ 18 years
8. LVEF ≥50% measured by echocardiography or MUGA
9. Eligible for neoadjuvant treatment
10. Laboratory requirements within 21 days prior to enrollment:

    1. Adequate bone marrow function (ANC ≥1.5 x 109/l, platelets ≥100 x 109/l);
    2. Adequate hepatic function (ALAT, ASAT and bilirubin ≤2.5 times upper limit of normal). Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists.
    3. Adequate renal function: creatinine clearance \>50 ml/min estimated using the Cockcroft-Gault equation or MDRD equation, or based on a 24-hour urine collection measurement.

Exclusion Criteria:

1. Current pregnancy or breastfeeding
2. Current or previous other malignancy unless treated without systemic therapy and more than five years ago
3. Psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
4. Use of a strong CYP3A4 or CYP2C8 inhibitor within five half-lives of the inhibitor, or used a strong CYP3A4 or CYP2C8 inducer within five days prior to first dose of study treatment
5. Known chronic liver disease
6. History of inflammatory bowel disease or bowel resection
7. Contraindications for MRI
8. Inflammatory breast cancer, cT4 and/or cN3 tumors
9. Occult breast cancer (cT0)

Where it's running

• Netherlands Cancer Institute
  Amsterdam, Netherlands Recruiting

Similar studies

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

• Tucatinib with trastuzumab and capecitabine for HER2‑positive metastatic breast cancer in routine care

  This project will see if tucatinib combined with trastuzumab and capecitabine works and is safe for people with HER2‑positive metastatic breast cancer who have had at least two prior anti‑HER2 treatments.

  Recruiting at 13 sites Fondazione Oncotech · Avellino, AV and 29 other locations · NCT07583485

• Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens

  We will test whether two different pre-surgery drug combinations clear tumor DNA from the blood better in people with HER2-positive early breast cancer.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai · NCT07335081

• TQB2102 versus docetaxel with trastuzumab and pertuzumab for HER2-positive recurrent or metastatic breast cancer

  This trial will test whether TQB2102 works as well as docetaxel plus trastuzumab and pertuzumab for adults with HER2-positive recurrent or metastatic breast cancer.

  Recruiting Phase 3 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Hefei, Anhui and 24 other locations · NCT07003074

• Vaccine targeting HER2 in locally advanced breast cancer

  This trial will test a vaccine that boosts the immune system to attack HER2-positive breast cancer in adults with locally advanced or high-risk disease.

  Recruiting Phase 1 Indiana University · Indianapolis, Indiana · NCT06949410

• Short-course treatment for early HER2-positive breast cancer

  This study is testing a shorter treatment plan with two medications for early HER2-positive breast cancer to see if it works just as well as the usual year-long treatment but with fewer side effects.

  Recruiting Phase 2 Shanghai Jiao Tong University School of Medicine · Shanghai, Shanghai Municipality · NCT05891561

• Combination treatment for HR+/HER2+ breast cancer

  This study is testing a new combination treatment for patients with stage II-III HR+/HER2+ breast cancer to see if it works better than the standard treatment before surgery.

  Recruiting Phase 2 Shengjing Hospital · Shenyang, Liaoning · NCT05638594

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.