Active, not recruiting • Phase I, II • Stage III, IV • Post-Menopausal • Brain Metastases present • Interventional
The following is imported from ClinicalTrials.gov:
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2.
The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.
Actual study start date:
December 28, 2020
Ages eligible for study:
18 - 999
Sexes eligible for study:
Arms and Intervention
patients must be at least 18 years of age
pathologically documented breast cancer that:
is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
her2-positive (ihc 3+ or ihc 2+/ish+) based on local assessment. the local her2 result must be from a tumour sample obtained in the metastatic setting.
is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
patient must have adequate tumor sample from the metastatic setting for biomarker assessment
ecog performance status of 0 or 1
disease progression on or after the last systemic therapy prior to starting study treatment
at least 1 prior treatment line in metastatic setting required.
part 2 (modules 0 - 5)
a) no prior lines of therapy for advanced/mbc allowed
part 2 (module 6 and 7) a) zero or one prior lines of therapy for advanced/mbc allowed
modules 0 - 5 patients must have no brain metastases or stable brain metastases.
module 6 and 7 patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy
uncontrolled or significant cardiovascular disease
active or prior documented (non-infectious) ild/pneumonitis that required steroids, or suspected ild/pneumonitis that cannot be ruled out by imaging at screening
uncontrolled infection requiring iv antibiotics, antivirals, or antifungals
spinal cord compression or a history of leptomeningeal carcinomatosis
prior treatment with immune checkpoint inhibitors
prior treatment with an adc containing a topoisomerase i inhibitor
prior treatment with tucatinib
modules 0 - 5: has untreated brain metastasis
module 6 and 7: ongoing use of systemic corticosteroids for control of symptoms of brain metastases at a total daily dose of > 2 mg dexamethasone or any brain lesion thought to require immediate local therapy