Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04578106
Other study ID # HCB-ONC001 (ML41519)
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 23, 2020
Est. completion date December 2026

Study information

Verified date May 2024
Source Fundacio Clinic Barcelona
Contact Laia Arenas
Phone 93 2275400
Email ELPIS@clinic.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, single arm, open-label, unicenter, exploratory study in women with primary operable HER2-positive, HER2-enriched/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab. The primary trial objective is to estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging (i.e. Magnetic resonance imaging) and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 17
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility Inclusion Criteria: 1. Female participants who are at least 40 years of age on the day of signing the informed consent form with histologically confirmed diagnosis of breast cancer. 2. A participant is eligible to participate if she is not pregnant, not breastfeeding. 3. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial. 4. Histologically confirmed invasive adenocarcinoma of the breast, with all of the following characteristics: - HER2-positive status by local determination according to 2018 ASCO/CAP guidelines. - PAM50 HER2-enriched subtype and ERBB2-high as predefined cutoff as per central determination. - Unifocal invasive carcinoma: only 1 invasive focus can be observed (the tumor focus containing or not containing an in situ component) - Tumor largest diameter =4 cm as defined by breast MRI. - No nodal involvement (i.e. cN0). Any suspicious axillary node by ultrasound must be biopsied. If the biopsy or the FNA is negative of tumor cells, patient is eligible. - No evidence of distant metastasis (M0) by routine clinical assessment. 5. Patient must have known ER and PR status locally determined prior to study entry. 6. Eligible for taxane therapy. 7. Willingness of the patient to omit surgery if all criteria are met following neoadjuvant therapy. 8. Estimated life expectancy of at least 5 years irrespective of the diagnosis of breast cancer. 9. Breast cancer eligible for primary surgery 10. Have provided archival tumor tissue sample or newly obtained core. Formalin-fixed,paraffin embedded (FFPE) tissue blocks are mandatory. Available pre-treatment FFPE core biopsy evaluable for PAM50 or possibility to obtain one. 11. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 12. Ability and willingness to comply with study visits, treatment, testing and to comply with the protocol. 13. Have adequate organ function. Exclusion Criteria: 1. Has received prior anti-cancer therapy, including investigational agents, or treatment for primary invasive breast cancer. 2. Known hypersensitivity to any of the excipients of trastuzumab, pertuzumab, TDM1 or paclitaxel. 3. Clinical stage II, III or IV. 4. History of radiotherapy in the ipsilateral breast or axilla. 5. History of surgery of the ipsilateral axilla. 6. Bilateral invasive breast cancer. 7. Infiltrating lobular carcinoma. 8. Multicentric or multifocal breast cancer, defined as the presence of two or more foci of cancer in the same or different quadrants of the same breast. 9. Patients who have undergone sentinel lymph node biopsy prior to study treatment. 10. Patient has active cardiac disease or a history of cardiac dysfunction 11. Has an active infection requiring systemic therapy. 13. Patients with a history of previous breast cancer are excluded.

Study Design


Intervention

Biological:
Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination
After 13 weeks of neoadjuvant treatment, a breast MRI will be performed. If a complete response is observed on breast MRI, patients will undergo a stereotactic-guided VAB of the marker area to obtain 12 cylinders of breast parenchyma, which is equivalent to 2 grams of tissue. If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB, patients will be eligible to omit loco-regional surgery.

Locations

Country Name City State
Spain Hospital Clinic de Barcelona Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Fundacio Clinic Barcelona Roche Pharma AG, SOLTI Breast Cancer Research Group

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary To evaluate the possibility of omission of surgery and sentinel lymph node dissection in clinically low-risk HER2-positive breast cancer with high HER2 addiction and a complete response following standard neoadjuvant chemotherapy and dual HER2 blockade. To estimate the loco-regional invasive disease-free survival (LR-IDFS) at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery. 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT04095390 - A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer Phase 2
Terminated NCT01912963 - Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer Phase 2
Completed NCT01855828 - Phase 2 Trial of Pertuzumab and Trastuzumab With Weekly Paclitaxel and Chemotherapy for HER2 Positive Breast Cancer Phase 2
Terminated NCT01705340 - Akt Inhibitor MK2206, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With Locally Advanced or Metastatic HER2-Positive Breast , Gastric, or Gastroesophageal Cancer That Cannot Be Removed By Surgery Phase 1
Recruiting NCT04094896 - TCHP Versus EC -THP as Neoadjuvant Treatment for HER2-Positive Breast Cancer Phase 2
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT05346861 - Pyrotinib Rechallenge in Her2-positive Metastatic Breast Cancer Pretreated With Pyrotinib and Trastuzumab Phase 3
Recruiting NCT04899908 - Stereotactic Brain-directed Radiation With or Without Aguix Gadolinium-Based Nanoparticles in Brain Metastases Phase 2
Completed NCT03330561 - PRS-343 in HER2-Positive Solid Tumors Phase 1
Recruiting NCT04997798 - Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer Phase 2
Not yet recruiting NCT04034823 - KN035 in Combination With Trastuzumab and Docetaxel in HER2-positive Breast Cancer Phase 2
Completed NCT04756921 - 18F-FDG Uptake Heterogeneity Predicts Pyrotinib Response
Completed NCT03140553 - TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer Phase 2
Completed NCT03094052 - Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib Phase 2
Recruiting NCT05511844 - Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors Phase 1
Recruiting NCT05325632 - Study of HER2 Directed Dendritic Cell (DC1) Vaccine + Weekly Paclitaxel, Trastuzumab & Pertuzumab Phase 2
Recruiting NCT06161922 - Real World Patient-Reported Outcomes in Chinese Her2+ EBC Patients Receiving (Neo) Adjuvant Anti-Her2 Based Therapy
Recruiting NCT05710666 - Neoadjuvant Trastuzumab Deruxtecan (T-DXd) With Response-directed Definitive Therapy in Early Stage HER2-positive Breast Cancer (SHAMROCK Study) Phase 2
Not yet recruiting NCT05063643 - Cardiotoxicity of Targeted Therapy for HER-2 Positive Breast Cancer Patients at High Altitude
Not yet recruiting NCT03684863 - Capecitabine in HER-2 Positive Breast Cancer With Pathologic Residual Tumors After Preoperative Chemotherapy Phase 2