The p53 breast cancer trial

You may be able to join if

• Primary (T2 tumors or Locally advanced breast cancers; LABC) in need of pre-surgical chemotherapy or metastatic breast cancer in need of chemotherapy.
• Before patient registration, written informed consent must be given according to national and local regulations.
• Blood test requirements: ▪ Neutrophils > 1.0 x 109/L ▪ Platelets > 75 x 109/L ▪ Bilirubin < 20 μmol/L. ▪ Serum creatinine < 1.5 x ULN
• Resistance to endocrine therapy: Either i) estrogen and progesterone negative tumor, or ii) harboring an estrogen and / or progesterone positive tumor where regular endocrine therapies have failed or where the treating physician finds endocrine therapy not indicated
• Prior cancer therapy: Metastatic disease: First line treatment: No prior chemotherapy*. Prior endocrine therapy +/- CDK4/6 inhibitor or mTOR inhibitors is allowed if hormone receptor positive, HER2 negative disease. * Only for patients with TP53 mutated disease. Previous adjuvant chemotherapy, including alkylating agents (cyclophosphamide a.o.) DocuSign Envelope ID: 00482556-BD7E-48A0-B3D5-54A7D3046AD9 Study protocol: The p53 breast cancer trial, version 1.9 24 and/or platinum, is allowed if completed >12 months prior to inclusion in the trial. Late-stage disease (approved protocol): i) Prior exposure to and resistance to a taxane regimen**. ii) Prior exposure to and resistance to an anthracycline regimen*** - iii) Previous adjuvant chemotherapy, including alkylating agents (cyclophosphamide a.o.) and/or platinum, is allowed if completed >12 months prior to inclusion in the trial. Primary breast cancer (T2 tumors or LABC): i) Prior exposure to and lack of response to a taxane regimen**. ii) Prior exposure to and lack of response to an anthracycline regimen*** *** Mandatory only for patients with TP53 wt tumors. ** For HER2 positive breast cancer, previous taxane + anti-HER2 treatment is required. In metastatic breast cancer resistance to taxanes/anthracyclines is defined as progressive disease (PD). In primary breast tumors lack of response is defined as stable disease (SD) after 4 courses of chemotherapy or PD, or SD/PD after initial response, or further taxane/anthracyclines is not possible due to toxicity. Breast cancer relapsing within 12 months subsequent to adjuvant taxanes or anthracyclines is considered resistant and re-exposure is not required prior to inclusion in the trial. This relates also to patients who could not receive proper taxane or anthracycline therapy due to side effects or other medical reasons.
• The primary tumor or at least one metastatic lesion must be available for biopsy collection at protocol inclusion. Notably; for patients with primary metastatic breast cancer, TP53 status should be determined in a metastatic deposit; tissue from the primary tumor may not substitute (this relates both to patients with synchronous and metachronous metastatic disease).