Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Invitation for breast screening and random allocation. Participants randomised to DBT will be screened with bilateral, two-view combo mode (DBT images are obtained with DM images). DBT participants will have an additional radiation exposure for the combined DM and DBT examinations.

Invitation for breast screening and random allocation. Participants randomised to DM will be screened with bilateral, two-view DM.

Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.

Invitation for breast screening and random allocation

Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.

Conventional digital mammography.

Alfonso Frigerio, Dr

Preliminary results from prospective screening trials show that Digital Breast Tomosynthesis (DBT) is more sensitive and more specific than conventional digital mammography (DM). However, large randomised controlled trials (RCTs) are needed to confirm these promising results. Furthermore, potential side effects of DBT in the screening setting have to be properly evaluated. In particular, the major concern is about overdiagnosis and its consequences; overdiagnosis refers to the detection of cancers at screening, which would not have become clinically apparent in the woman's lifetime.

This RCT was designed to compare benefits and harms of DBT in a population-based screening program with conventional DM. The primary outcome parameter will be the difference between the two tests in rates of advanced cancers detected at the subsequent round and interval cancers (within the first two years after the study screening round). Secondary outcomes measures will be diagnostic performance indicators for organised breast screening (i.e, cancer detection rate, recall rate, false positive rate, positive predictive value), parameters used in cost-effectiveness analysis, pathologic and biological characteristics of screen-detected cancers.

Design of the study This trial will involve several hospital centres within the organised breast screening in the Italian region of Piedmont.

An invitation letter to participate in a randomised screening trial comparing DBT versus DM will be mailed to all women, 46-68 years old, living in the Piedmont Region, and eligible for invitation to the regional mammography screening program. Women who attend the centres for screening and consent to the study will be randomly allocated either to DBT or DM arm.

Women in the DM arm will be screened with bilateral, two-views digital mammography examination. Women in the DBT arm will be screened with the bilateral two-views combo mode (DM and DBT images acquired in a single compression). In both screening arms, examinations will be independently read by two expert screening radiologists. In the DBT arm, each reading will be randomly allocated (on a per-case basis) to one of these three modes: DM plus DBT (DBT is read only after initial DM interpretation), DBT plus DM (DM is read only after DBT interpretation) and "concurrent mode" (both DBT and DM are read simultaneously).

In both screening arms, participants will be recalled for further examination if indicated by at least one radiologist (without consensus or arbitration). At the subsequent round all participants will be invited to DM only. Interval cancers and advanced cancers screen-detected at the next round will be recorded. Pathological and biological parameters of screen-detected cancers (e.g, stage, grading, hormone receptors, HER2) in both screening arms will be measured to investigate overdiagnosis.

With a sample size of 23,000 and 69,000 women in the DBT and DM arm respectively, the investigators will be able to observe a significant decrease in interval cancers and advanced cancers rate of at least 50% (power 80%, two tails). The collected data will be also used to perform analyses on radiological work-flow and workload, and cost-outcome and cost-effectiveness.

Tomosynthesis Versus Digital Mammography in a Population-based Screening Program

Digital Breast Tomosynthesis Versus Digital Mammography in a Population-based Screening Program. A Controlled Randomized Multicenter Trial

Regione Piemonte

im3D S.p.A.

Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Squamous Cell

Lung Neoplasms

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 1 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 2 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 3 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 4 on Day 1 of each cycle Q3W

Enrolled Subjects will receive a single-dose of DB-1310 at Dose Level 5 on Day 1 of each cycle Q3W

Enrolled Subjects with advanced/unresectable, or metastatic adenocarcinoma NSCLC with EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Enrolled Subjects with advanced/unresectable, or metastatic NSCLC without EGFR activating mutation who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Enrolled Subjects with advanced/unresectable, or metastatic CRPC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Enrolled Subjects with advanced/unresectable, or metastatic HNSCC who have progressed on or after standard systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Enrolled Subjects with advanced/unresectable, or metastatic BC with HER2-positive (IHC3+, or IHC2+ and ISH+) who have progressed on or after HER2 targeted systemic treatments will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

Enrolled Subject with other advanced/unresectable, or metastatic solid tumors who have progressed on or after standard systemic treatment, or for which no standard systemic treatment is available will receive a single-dose of DB-1310 on a selected dose level (RP2D) Day 1 of each cycle Q3W

DB-1310

Jenny Li

Wei Wang

Tianhong Li, PhD

Aaron E. Lisberg, MD

David Kahn, MD

Cesar Batista, MD

H Amin, MD

Judy SZ Wang, MD

Chintan Gandhi

Julia Rotow, MD

Amy Weise, DO

Alexander Starodub, MD, PhD

Erika P. Hamilton, MD

A Spira, MD

Qiming Wang

Lin Wu

Yong mei Yin

Yong Mao

Jiuwei Cui

Ming fang Zhao

Shun Lu

Haitao Lan

Raymond Zhao, MD

This is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1310 in subjects with advanced solid tumors.

This is a multicenter, non-randomized, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts the standard "3+3" design to identify the MTD and/or RP2D; Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1310 as monotherapy or in combination with trastuzumab.

A Study of DB-1310 in Advanced/Metastatic Solid Tumors

A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1310 in Subjects With Advanced/Metastatic Solid Tumors

Percentage of participants in Part 1 with DLTs

Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0assessed by CTCAE v5.0.

Percentage of participants with AEs in Part 1 graded according to NCI CTCAE v5.0

Percentage of Participants with SAEs in Part 1 graded according to NCI CTCAE v5.0

RP2D of DB-1310 based on the data collected during Part 1

Percentage of participants with AEs in Part 2 graded according to NCI CTCAE v5.0

Percentage of participants with SAEs in Part 2 graded according to NCI CTCAE v5.0

The percentage of subjects who had a best response rating of CR and PR, for Part 2 only which was maintained ≥4 weeks

Area under the concentration-time curve from time 0 to infinity of DB-1310

Maximum observed plasma concentration (Cmax) of DB-1310

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Tomosynthesis Versus Digital Mammography in a Population-based Screening Program	NCT02590315	Breast Cancer	Invitation for ... DBT Conventional di...	46 Years - 68 Years	Centro di Riferimento per l'Epidemiologia e la Prev. Oncologica Piemonte
A Study of DB-1310 in Advanced/Metastatic Solid Tumors	NCT05785741	Advanced Solid ...	DB-1310	18 Years -	DualityBio Inc.

Spots Global Cancer Trial Database for bc

Every month we try and update this database with for bc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for bc

Every month we try and update this database with for bc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for bc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.