TRASTUZUMAB for Breast cancer | HER2-positive breast cancer

Inclusion criteria

• {"criterion_text":"- Histologically confirmed primary infiltrating breast cancer"}
• {"criterion_text":"- Women of childbearing potential and men must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods (failure rate of <1% per year,) during treatment and for at least seven months after the last dose of pertuzumab/Herceptin®. A woman is considered to be of childbearing potential if she is post‐menarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus)."}
• {"criterion_text":"- Women who are not postmenopausal (≥12 months of non−therapy‐induced amenorrhea) or surgically sterile must have a negative β‐HCG serum or urine pregnancy test result."}
• {"criterion_text":"- Stage II or III disease according to TNM‐staging (8th edition, AJCC). Nodal status must be examined by ultrasound and fine‐needle aspiration or core biopsy in case of suspicious lymph nodes."}
• {"criterion_text":"- Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to ASCO/CAP 2013 guideline (locally assessed)"}
• {"criterion_text":"- Known estrogen‐ and progesteron‐receptor expression of the invasive tumor"}
• {"criterion_text":"- Age ≥18"}
• {"criterion_text":"- WHO performance status ≤1"}
• {"criterion_text":"- Visible breast tumor on contrast enhanced MRI and/or the presence of malignant lymph node(s)"}
• {"criterion_text":"- Laboratory requirements – within 21 days prior to enrolment: 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); 3) Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists; 4) Adequate renal function: creatinine clearance >50 ml/min estimated using the Cockcroft‐Gault equation, or based on a 24‐hour urine collection measurement"}
• {"criterion_text":"- LVEF ≥50% measured by echocardiography, MUGA, or MRI"}

Exclusion criteria

• {"criterion_text":"- Concurrent breastfeeding"}
• {"criterion_text":"- Evidence of distant metastases on FDG‐PET"}
• {"criterion_text":"- Concurrent contralateral or ipsilateral second primary infiltrating breast cancer"}
• {"criterion_text":"- Concurrent anti‐cancer treatment or another investigational drug"}
• {"criterion_text":"- Contra‐indication for neoadjuvant chemotherapy"}
• {"criterion_text":"- Other invasive malignancy unless treated without chemotherapy more than five years ago and without evidence of recurrence. Patients with prior adequately treated basal cell or squamous cell skin cancer are also eligible."}
• {"criterion_text":"- Peripheral neuropathy ≥ grade 2 CTCAE v5.0"}

Primary endpoints

• {"endpoint_text":"- Three-year event-free survival","definition_or_measurement_approach":"Measured as event-free survival at three years (three-year EFS)."}

Secondary endpoints

• {"endpoint_text":"- Overall survival (OS), defined as the time from registration to death from any cause.","definition_or_measurement_approach":"Defined as the time from registration to death from any cause."}
• {"endpoint_text":"- Pathologic complete response in breast and axilla, defined as the absence of invasive tumor cells, irrespective of the presence of in-situ lesions","definition_or_measurement_approach":"Defined as the absence of invasive tumor cells in breast and axilla, irrespective of presence of in-situ lesions."}
• {"endpoint_text":"- Radiologic complete response, defined as the absence of pathologic enhancement on MRI and normalization of possible lymph node involvement at ultrasound and FNA examination","definition_or_measurement_approach":"Defined as the absence of pathologic enhancement on MRI and normalization of possible lymph node involvement at ultrasound and FNA examination."}
• {"endpoint_text":"- Concordance between radiologic response and pathologic response: difference in EFS and OS between patient with rCR after 3, 6, and 9 cycles","definition_or_measurement_approach":"Comparison of EFS and OS between patients with radiologic complete response (rCR) after 3, 6, and 9 cycles versus others."}
• {"endpoint_text":"- Difference in EFS and OS between patient with pCR after 3, 6, and 9 cycles","definition_or_measurement_approach":"Comparison of EFS and OS between patients with pathologic complete response (pCR) after 3, 6, and 9 cycles versus others."}
• {"endpoint_text":"- Difference in radical resections in rCR and no‐rCR","definition_or_measurement_approach":"Comparison of rates of radical surgical resection between patients with rCR and those without rCR."}
• {"endpoint_text":"- Health‐related quality of life","definition_or_measurement_approach":"Assessed using patient-reported instruments (EORTC QLQ‐30 and QLQ‐BR45 as described in objectives)."}

Netherlands

Earliest CTIS Part Ii Submission Date

26-07-2024

Latest Decision Or Authorization Date

12-11-2024

Processing Time Days

109

Number Of Sites

43

Number Of Participants

472

Primary sponsor

Full Name

BOOG Study Center B.V.

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"Netherlands","full_name":"Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting","duties_or_roles":"Codes: 1,10,11,13,4,6,7,8","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Netherlands","full_name":"IKNL","duties_or_roles":"Codes: 7","organisation_type":"Laboratory/Research/Testing facility"}