
Risk-Based Breast Screening in Young Women
Breast NeoplasmsThe RIBBS study is a single-arm single-center study that aims to evaluate the effectiveness of a risk-based breast screening model using digital breast tomosynthesis (DBT) as the baseline test, quantitative individual breast density to guide supplemental ultrasound (US) imaging for dense breasts, and individual risk (calculated taking into account breast density) to guide the screening interval (annual or biennial). Invited 45-year-old women are differentiated into five different screening protocols (based on breast density and risk), and screened according to a personalized model until they turn 50 and return to routine screening. The only primary endpoint in this study is the cumulative incidence of advanced breast cancers (stage II and above). This endpoint will be evaluated at the end of the five-year intervention period and at 10 years. The results of the personalized screening model will be compared with those obtained from an observational cohort from a neighboring region in which a "one-size-fits-all" approach involving annual mammography for women aged 45-49 years is used. The comparison will be conducted with the hypothesis of superiority of the personalized screening model.

ACT-MBC: A Study of Circulating Tumor Cells (CTCs) in Metastatic Breast Cancer (MBC)
Metastatic Breast CancerACT-MBC prospectively assesses the impact of CTCs on treatment decisions, response assessment and prognosis in MBC patients.

Phase II Clinical Study of T-DM1 and Pyrotinib Maleate in Patients With HER2-positive Metastatic...
HER2+ Advanced Breast Cancer Patients Progressing on TKI TherapyThis trial is a combination of trastuzumab and pyrotinib in the treatment of patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy. A total of 50 patients were enrolled in the study design. Preliminary efficacy and safety in patients with HER2-positive metastatic breast cancer who have progressed on TKI therapy.

A Randomized Trial of Five Fraction Partial Breast Irradiation
Breast Neoplasm FemaleRadiotherapy1 moreThe primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.

Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
Breast CancerBenign Breast Disease1 moreBreast cancer incidence is increasing in low- and middle-income countries (LMICs) and breast cancer mortality is high in these regions largely due to late stage diagnoses. This is true in the low-income East African country of Rwanda, where there are no national protocols in place to guide evaluation and referral of breast symptoms at primary health facilities. This study will use quantitative and qualitative methods to examine implementation of the Women's Cancer Early Detection Program (WCEDP) in order to understand optimal strategies to scale and sustain breast cancer early diagnosis in Rwanda and other limited-resource settings. The WCEDP is an adaptation of a prior intervention in Burera District, which focused on building community awareness of breast symptoms, improving clinicians' clinical breast assessment (CBA) skills, and implementing weekly breast clinics at the primary health care center and hospital levels. The Burera intervention was associated with improvements in health care workers' knowledge and skills, increases in care-seeking and receipt of care by women with breast symptoms, and an increase in early-stage breast cancer diagnoses.

Evaluation of Treatment Efficacy by Circulating Tumor Cell Phenotype Surveillance in Breast Cancer...
Breast NeoplasmsNeoplastic Cells2 moreThe phenotype of circulating tumor cells (CTCs) is supposed to be significant indicator that is correlated the prognosis of breast cancer patients who have completed neoadjuvant chemotherapy, primary tumor surgery with/without adjuvant chemotherapy. The aim of this observational study is to assess the efficacy of CTCs surveillance in predicting the prognosis of breast cancer patients.

CIPHER Study: Pilot Study to Study the Role of ctDNA in Triple Negative and HER2 Positive Early...
Breast CancerEarly-OnsetPrimary Objective: 1) To examine the impact of Circulating tumor DNA (ctDNA) (expressed as mean tumor molecules per ml) on treatment decision making in patients with early stage breast cancer after neoadjuvant therapy and surgery Secondary Objectives: Understand ctNDA kinetics in the neoadjuvant and adjuvant setting To identify any associations between clinical staging and measurable ctDNA

Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast...
Metastatic Breast CancerLocoregional (LRT) of the primary tumor in de-novo metastatic breast cancer (dnMBC) is no longer only a surgical challenge, but more the final decision of a multidisciplinary tumor board including medical oncologists, radiation oncologists and surgical oncologists. It is no longer only a question of locoregional control but rather a wider issue of improving overall survival (OS), due to the possible biological link between primary tumor and metastases. A multimodal approach, including LRT with curative intent should be considered for selected dnMBC patients, especially for the subset of bone-only metastatic ones.

Study Evaluating DNA Double-strand Breaks (DSBs) REpair Factors (POLQ, Shieldin Complex and 53BP1)...
Breast CancerThe purpose of this study is to assess whether expression of not only POLQ/Polθ, but also Shieldin complex and/or 53BP1 are correlated with primary and/or acquired resistance to PARPi (Poly(ADP-Ribose) Polymerases inhibitors) in a sub-population of locally advanced or metastatic breast cancer patients and vary regarding type and location of gBRCA1/2 mutations. This translational research program is composed of two multicentric, non-randomized prospective studies in patients with HER2-negative locally advanced or metastatic breast cancer: The main study concerns 80 patients eligible for PARPi (according to the investigators).PARPi treatments (talazoparib or olaparib) will be administered and dosed according to the standard of care administration. The sub-study concerns 40 patients in progression disease under PARPi alone. For each included patient in the main study or sub-study, tumor biopsy specimen and blood samples will be collected at different times during the study.

Weekly Utidelone in HER2-negative Inoperable Locally Advanced or Metastatic Breast Cancer
Breast NeoplasmsLocally Advanced or Metastatic Breast CancerThis is a phase II trial to explore the efficacy and safety of weekly utidelone in HER2-negative inoperable locally advanced or metastatic breast cancer.