Pre-operative study for breast cancer with nivolumab in combination with other therapy

Phase 1

• Conditions: MedDRA version: 20.0Level: LLTClassification code 10006194Term: Breast cancer NOS stage ISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10006196Term: Breast cancer NOS stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; MedDRA version: 21.1Level: LLTClassification code 10006188Term: Breast cancer female NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10006195Term: Breast cancer NOS stage IISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2018-004188-30-NL
• Lead Sponsor: KI-AV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-26
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Signed written informed consent
• 18 years or older at moment of inclusion;
• Female and male gender;
• WHO performance status 0 or 1;
• Resectable primary breast cancer stage I-III. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan (cohort 3B, 4B and 5B: PET-CT mandatory).
• Patients indicated for neoadjuvant chemotherapy will also be eligible, whereby a new dedicated biopsy is performed before the beginning of the chemotherapy. Adjuvant systemic treatment is allowed if indicated according to local guidelines.
• The tumors must be:
o at least 5 mm (minimum cT1b) as determined by MRI
o TNBC defined as ER<10%, HER2-negative OR luminal B defined as ER=10%, HER2-negative with either Ki67=20% or PR =20% OR grade 3. HER2 negative is defined as an IHC score of <2 or 2+ with a negative ISH.
oFor TNBC patients: TIL=5%
oFor LumB breast cancer patients: TIL=1%
oFor cohort 3B: N0 status
oFor cohort 4B: N0 status, TNBC and TIL 30-49%
o or cohort 5B: N0 status, TNBC and TIL =50%

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• evidence or suspicion of metastatic disease. Evaluation of the presence of distant metastases may include chest X-ray, liver ultrasound, isotope bone-scan, CT-scan of chest and abdomen and/or FDG-PET scan, according to local procedures;
• other prior invasive malignancy 1) in the breast or 2) localized in the near proximity of the breast, that was treated with radiotherapy at the localization of the new breast tumor;
• Concurrent ipsilateral or contralateral disease of the primary or a secondary tumor is allowed, as long as the other lesions is not a distant metastasis.
• Locoregional recurrences are not allowed. Second primary tumors are allowed in the study;
• occult breast cancer;
• previous anti-cancer hormone therapy or chemotherapy;
• prior treatment with checkpoint inhibitors (including anti- PD1, -PD-L1, -CTLA-4, -LAG3);
• concurrent anti-cancer treatment, neoadjuvant therapy or another investigational drug;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified