RECRUITING

DATO-BASE: DATOpotamab-deruxtecan for Breast Cancer Brain MetAstaSEs

Conditions

Breast Cancer Breast Cancer Female Metastatic Triple-Negative Breast Carcinoma ER Positive Breast Cancer HER2-negative Breast Cancer HER2 Negative Breast Carcinoma ER-negative Breast Cancer HER2 Negative Breast Cancer ER Negative Breast Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to test the safety and effectiveness of the study drug datopotamab deruxtecan in participants with metastatic breast cancer that has spread to the brain. The name of the study drug used in this research study is: Datopotamab deruxtecan (a type of antibody-drug conjugate)

Official Title

DATO-BASE: a Phase 2 Trial of DATOpotamab-deruxtecan for Breast Cancer Brain MetAstaSEs

Quick Facts

Study Start:2023-12-26

Study Completion:2029-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06176261

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	* Visceral crisis or impending visceral crisis * CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement) * Indication for immediate local therapy to CNS lesion(s) as defined by local standard * Evidence of significant (i.e., symptomatic) intracranial hemorrhage * Ongoing/persistent toxicities caused by previous anti-cancer therapy (except alopecia) not yet improved to Grade ≤ 1 OR baseline prior to study entry (registration) * Known contraindication to MRI (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity). However, for cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT. * Concurrent administration of other anti-cancer therapy during the course of this study is not allowed. Concurrent use of supportive care medications is allowed, and certain medications are required (see Section 5.1). * Uncontrolled intercurrent illness, including (but not limited to) active infection, severely compromised pulmonary function, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ischemic heart disease, myocardial infarction within the previous six months, gastric or duodenal ulceration diagnosed within the previous six months, chronic liver or renal disease, or severe malnutrition. Note that if a patient has controlled diabetes mellitus, but is unable to monitor blood glucose at home, they will be excluded from the trial. * Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\>4 mg daily dexamethasone (or bioequivalent)) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion. * History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * A history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs. * A history of malignancy other than breast cancer, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥ 3 years. * Major surgery, open biopsy, or significant traumatic injury within 28 days prior to the initiation of protocol therapy, or anticipation of need for a major surgical procedure during the study. * Clinically significant corneal disease. * Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of datopotamab deruxtecan. * History of severe hypersensitivity reactions to other monoclonal antibodies * Negative pregnancy test (urine and/or serum) is required for women of childbearing potential. Pregnant or lactating women are excluded from participation due to potential teratogenic effects of study drug. * Female participants must be either: * post-menopausal for at least 1 year * surgically sterile, or * if of childbearing potential and sexually active with a non-sterilized male partner, must agree to use one highly effective form of birth control for the entire treatment period and for at least 7 months after the last dose of datopotamab deruxtecan (see Section 5.4 for complete list of highly effective birth control methods). * Female participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of datopotamab deruxtecan. * Female participants must refrain from breastfeeding while on study and for at least 7 months after the last dose of datopotamab deruxtecan. * Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (see Section 5.4 for complete list of highly effective birth control methods) from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

* Visceral crisis or impending visceral crisis
* CNS complications for whom urgent neurosurgical intervention is indicated (i.e., resection, shunt placement)
* Indication for immediate local therapy to CNS lesion(s) as defined by local standard
* Evidence of significant (i.e., symptomatic) intracranial hemorrhage
* Ongoing/persistent toxicities caused by previous anti-cancer therapy (except alopecia) not yet improved to Grade ≤ 1 OR baseline prior to study entry (registration)
* Known contraindication to MRI (e.g., due to pacemaker, ferromagnetic implants, claustrophobia, extreme obesity, hypersensitivity). However, for cohorts A and B, head CT with contrast may be used in place of MRI at baseline and throughout the trial if MRI is contraindicated and the participant's CNS metastases are clearly measurable by head CT.
* Concurrent administration of other anti-cancer therapy during the course of this study is not allowed. Concurrent use of supportive care medications is allowed, and certain medications are required (see Section 5.1).
* Uncontrolled intercurrent illness, including (but not limited to) active infection, severely compromised pulmonary function, unstable angina pectoris, uncontrolled cardiac arrhythmia, active ischemic heart disease, myocardial infarction within the previous six months, gastric or duodenal ulceration diagnosed within the previous six months, chronic liver or renal disease, or severe malnutrition. Note that if a patient has controlled diabetes mellitus, but is unable to monitor blood glucose at home, they will be excluded from the trial.
* Participants must not have a condition requiring ongoing systemic treatment with corticosteroids (\>4 mg daily dexamethasone (or bioequivalent)) or other immunosuppressive medications within 7 days prior to the baseline MRI. Corticosteroids administration must be stable and planned to remain ≤ 4 mg daily for the duration of protocol treatment. However, use of corticosteroids for clinical symptoms is allowed based upon treating physician discretion.
* History of non-infectious interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* A history of uncontrolled seizures, CNS disorders, or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs.
* A history of malignancy other than breast cancer, except (a) adequately resected non-melanoma skin cancer, (b) curatively treated in situ disease, or (c) other solid tumors curatively treated, with no evidence of disease for ≥ 3 years.
* Major surgery, open biopsy, or significant traumatic injury within 28 days prior to the initiation of protocol therapy, or anticipation of need for a major surgical procedure during the study.
* Clinically significant corneal disease.
* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of datopotamab deruxtecan.
* History of severe hypersensitivity reactions to other monoclonal antibodies
* Negative pregnancy test (urine and/or serum) is required for women of childbearing potential. Pregnant or lactating women are excluded from participation due to potential teratogenic effects of study drug.
* Female participants must be either:
* post-menopausal for at least 1 year
* surgically sterile, or
* if of childbearing potential and sexually active with a non-sterilized male partner, must agree to use one highly effective form of birth control for the entire treatment period and for at least 7 months after the last dose of datopotamab deruxtecan (see Section 5.4 for complete list of highly effective birth control methods).
* Female participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of datopotamab deruxtecan.
* Female participants must refrain from breastfeeding while on study and for at least 7 months after the last dose of datopotamab deruxtecan.
* Male participants who intend to be sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception (see Section 5.4 for complete list of highly effective birth control methods) from the time of screening throughout the total duration of the study and the drug washout period (at least 4 months after the last dose of study intervention) to prevent pregnancy in a partner. Male participants must not donate or bank sperm during this same time period.

Contacts and Locations

Study Contact

Sarah Sammons, MD

CONTACT

617-362-3800

sarahl_sammons@dfci.harvard.edu

Principal Investigator

Sarah Sammons, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Sarah Sammons, MD

Sarah Sammons, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-12-26

Study Completion Date2029-01-01

Study Record Updates

Study Start Date2023-12-26

Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Breast Cancer Female
Metastatic Triple-Negative Breast Carcinoma
ER Positive Breast Cancer
HER2 Negative Breast Cancer
HER2 Negative Breast Carcinoma
ER Negative Breast Cancer

Additional Relevant MeSH Terms

Breast Cancer
Breast Cancer Female
Metastatic Triple-Negative Breast Carcinoma
ER Positive Breast Cancer
HER2-negative Breast Cancer
HER2 Negative Breast Carcinoma
ER-negative Breast Cancer