A Study of Dato-DXd in Inoperable or Metastatic Hormone Receptor-positive, HER2 IHC 0 Breast Cancer
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
A study to assess the efficacy and safety of Dato-DXd in the pre-chemotherapy setting for patients with metastatic HR-positive, HER2 IHC 0 breast cancer.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must be ≥ 18 years (and above legal age) at the time of screening.
Inoperable or metastatic HR-positive, HER2 IHC 0 breast cancer (per ASCO/CAP guidelines, on local laboratory results); ie, is documented as HR-positive (either ER and/or PgR positive [ER or PgR ≥ 1%]) and HER2 IHC 0 (defined as including HER2 null with no staining or incomplete and faint/barely perceptible membrane staining in ≤ 10% of tumour cells) based on a fresh, or recent tissue sample obtained no more than 6 weeks prior to or during the screening period.
Progressed on and not suitable for further endocrine therapy per investigator assessment.
ECOG performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to the first dose of study intervention.
Disqualifiers
As judged by the investigator, any evidence of diseases (such as severe or uncontrolled systemic diseases, including active bleeding diseases and ongoing or active infection), history of allogenic organ transplant, and/or substance abuse which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardise compliance with the protocol.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before the first dose of study intervention and of low potential risk for recurrence. Exceptions include adequately resected non melanoma skin cancer (basal cell carcinoma of the skin or squamous cell carcinoma of the skin) and curatively treated in situ disease.
Chemotherapy-induced neuropathy
Fatigue
Trial design
Design model
Single group
Treatments tested in this trial
Dato-DXd
DrugAll participants will receive Dato-DXd (6 mg/kg IV on Day 1, Q3W; up to a maximum of 540 mg Q3W for participants ≥ 90 kg) until investigator-defined disease progression according to RECIST 1.1 or until unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met. Continued treatment with the same study drug post-progression may be allowed, based on prior discussion with sponsor/sponsor representative/study physician on a case-by-case basis following written investigator's confirmation of continuing clinical benefit to the patient post progression. The study is anticipated to enrol for an 18-month period, and DCO is expected to occur approximately 6 months after the last participant has been dosed.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: single arm groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression Free Survival (PFS) per RECIST 1.1 as assessed by the investigator
PFS is defined as time from date of first dose of study intervention until progression per RECIST 1.1 as assessed by the investigator or death due to any cause.
Time frame
From date of first dose of study intervention until disease progression per RECIST 1.1 or death from any cause, whichever occurs first, assessed up to approximately 24 monthsSecondary outcomes
1
Proportion of participants with oral mucositis/stomatitis
Proportion of participants with oral mucositis/stomatitis
Time frame
From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up)2
Proportion of participants with ocular events
Proportion of participants with ocular events
Time frame
From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up)3
Proportion of participants with Grade 3 or higher Adverse Events (AEs) possibly related to Dato-DXd treatment
Grade 3 or higher adverse events possibly related to Dato-DXd treatment (Grade ≥ 3 treatment-related adverse events) according to NCI CTCAE 5.0. Possibly related is defined as reasonable possibility that the adverse event was caused by investigational product, as assessed by investigator. Missing responses are counted as possibly related.
Time frame
From date of first dose of study intervention until 28 days after the last dose (Safety Follow-up)4
Clinical benefit rate (CBR) at 24 weeks
CBR at 24 weeks is defined as the percentage of participants who have a confirmed CR or PR or who have SD per RECIST 1.1 as assessed by the investigator and derived from the raw tumour data for at least 24 weeks after date of first dose.
Time frame
At 24 weeks after first doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
AstraZeneca
Lead sponsor
Daiichi Sankyo
Collaborator
Source ClinicalTrials.gov