Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Trastuzumab deruxtecan

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens.

Patients with unresectable or metastatic HER2-low breast cancer patients who have received at least a prior systemic therapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

Daiichi Sankyo China

Daiichi Sankyo Contact for Clinical Trial Information

Principal Investigator

Director

This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior anti-HER2-based regimens or patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+, ISH-) breast cancer who have received at least a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy.

The primary objective of the study is to evaluate real-world time to next treatment or date of death from index date (T-DXd treatment initiation date)(rwTTNT) in each cohort. The secondary objectives of this study are to describe treatment patterns in eligible patients with HER2+ or HER2-low unresectable or mBC who are newly initiating T-DXd in a real-world setting, to describe demographic and clinical characteristics, to assess the safety and tolerability through the collection of physician-reported SEIs, to characterize the management of SEIs, to evaluate real-world time to treatment discontinuation (rwTTD) of T-DXd, and to evaluate patient-reported tolerability.

This decision to treat the patient with T-DXd will be made prior to, and independent of, their participation in this study. Eligible patients willing to participate will be enrolled consecutively in the study and followed up from index date (T-DXd treatment initiation date) until end of study, death, or withdrawal of consent, or loss to follow-up (LTFU), or study closure, whichever occurs first.

A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

A Multi-center Prospective Observational Study to Assess the Effectiveness and Safety of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)

Time to next treatment or death from index date will be assessed.

Duration of treatment is defined as the length of time a patient is treated.

Time to discontinuation is defined as time from index date to the earliest date of T-DXd discontinuation, or date of death.

Daiichi Sankyo

Carcinoma

Antibodies

Immunoglobulins

Mitogens

HER2-positive or HER2-low, unresectable or metastatic BC.

BB-1701 will be administered as an intravenous infusion, every 3 weeks (21-day cycle).

BB-1701

Eisai Medical Information

The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2). The primary purpose of Dose Expansion (Part 2) is to assess the antitumor activity of BB-1701 at RD in the selected population(s) of breast cancer (BC).

For Dose Optimization (Part 1), this study is randomized and for Dose Expansion (Part 2), there will be no randomization.

A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer

An Open-label, Multicenter, Phase 2 Dose Optimization and Expansion Study to Evaluate the Safety and Efficacy of BB-1701, an Anti-human Epidermal Growth Factor Receptor 2 (Anti-HER2) Antibody-drug Conjugate (ADC), in Previously Treated Subjects With HER2-positive or HER2-low Unresectable or Metastatic Breast Cancer

Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product; Any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (example, electrocardiogram \[ECG\] or x-ray) that results in symptoms, a change in treatment, or discontinuation of study drug; Recurrence of an intermittent medical condition (example, headache) not present pretreatment (baseline); An abnormal laboratory test result should be considered an AE if the identified laboratory abnormality leads to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not. An AE does not necessarily have a causal relationship with the medicinal product.

Clinical laboratory parameters includes hematology, chemistry, and urinalysis.

Vital sign parameters includes systolic and diastolic blood pressure (BP), pulse, respiratory rate, body temperature.

Number of participants with clinically significant 12-lead ECGs values will be reported.

Number of participants with ECOG PS will be reported.

ORR is defined as the percentage of participants achieving a confirmed complete response (CR) or confirmed partial response (PR) by investigator assessment per Response Evaluation Criteria for Solid Tumours (RECIST) version (v) 1.1.

ORR is defined as the percentage of participants achieving a confirmed CR or confirmed PR based on BICR assessment per RECIST v1.1.

DOR defined as the time from the onset date of documented CR or PR for confirmed responses by investigator per RECIST v1.1 to the date of disease progression (PD) or death, whichever occurs first.

PFS is defined as the time from the date of first dose to the date of the first documentation of PD by investigator per RECIST v1.1 or death, whichever occurs first.

Overall survival (OS) is defined as the time from the date of first dose to the date of death. OS will be based on Kaplan-Meier estimates.

DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) (greater than or equal to \[\>=\] 5 weeks from the first dose) by investigator per RECIST v1.1.

CBR is defined as the percentage of participants with CR, PR, or durable SD (duration of SD \>=23 weeks) by investigator per RECIST v1.1.

TTR is defined as the time from the date of first dose to the day of the first documented CR or PR for confirmed responses by investigator per RECIST v1.1

DOR is defined as the time from the onset date of documented CR or PR for confirmed responses based on BICR by RECIST v1.1 to the date of PD or death, whichever occurs first.

DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) (\>=5 weeks from the first dose) based on BICR per RECIST v1.1.

TTR is defined as the time from the date of first dose to the day of the first documented CR or PR for confirmed responses based on BICR per RECIST v1.1

CBR is defined as the percentage of participants with CR, PR, or durable SD (duration of SD \>=23 weeks) based on BICR per RECIST v1.1.

PFS is defined as the time from the date of first dose to the date of the first documentation of PD based on BICR per RECIST v1.1 or death, whichever occurs first.

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product; Any new disease or exacerbation of an existing disease; any deterioration in non-protocol-required measurements of a laboratory value or other clinical test (example, ECG or x-ray) that results in symptoms, a change in treatment, or discontinuation of study drug; Recurrence of an intermittent medical condition (example, headache) not present pretreatment (baseline); An abnormal laboratory test result should be considered an AE if the identified laboratory abnormality leads to any type of intervention, withdrawal of study drug, or withholding of study drug, whether prescribed in the protocol or not. An AE does not necessarily have a causal relationship with the medicinal product.

Vital sign parameters includes systolic and diastolic BP, pulse, respiratory rate, body temperature.

Bliss Biopharmaceutical (Hangzhou) Co., Ltd

Eisai Inc.

HRS-8080 combined with Dalpiciclib Isethionate Tablets

HRS-8080; Dalpiciclib Isethionate Tablets

Min Li

Zefei Jiang, Doctor

This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion. Participants entering the study will receive HRS-8080 combined with Dalpiciclib Isethionate Tablets therapy.

Multi-center, open clinical study of HRS-8080 in conjunction with Dalpiciclib

Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer

A Multicenter, Open Phase Ib/II Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With ER-positive, HER2-negative Unresectable or Metastatic Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)	NCT06210776	HER2-positive B... HER2-low Breast... Breast Cancer Advanced Cancer	Trastuzumab der...	18 Years -	Daiichi Sankyo
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer	NCT06188559	Breast Cancer	BB-1701	18 Years -	Eisai Inc.
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer	NCT06167694	Unresectable or...	HRS-8080; Dalpi...	18 Years - 75 Years	Shandong Suncadia Medicine Co., Ltd.

Spots Global Cancer Trial Database for unresectable or metastatic breast cancer