Study of Trastuzumab Deruxtecan (DS-8201a, T-DXd) versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting
Key facts
- Where
- Budapest VI, Budapest XII, Budapest XIV, Győr, Kecskemét, Nyíregyháza és Szolnok, MagyarországSee the 7 sites
- Phase
- 3. fázis
Where in Magyarország
- Central Hospital Of Northern Pest Military HospitalBudapest VI, MagyarországNo longer taking part
- Orszagos Onkologiai IntezetBudapest XII, MagyarországNo longer taking part
- Budapesti Uzsoki Utcai KorhazBudapest XIV, MagyarországNo longer taking part
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato KorhazGyőr, MagyarországNo longer taking part
- Bacs-Kiskun Varmegyei OktatokorhazKecskemét, MagyarországNo longer taking part
- Szabolcs Szatmár Bereg Vármegyei OktatókórházNyíregyháza, MagyarországNo longer taking part
- Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-RendelointézetSzolnok, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca AB
- Trial code
- EU 2024-516653-44-00
- Record updated
- 2026. június 3.
- Original description
To assess the efficacy of Trastuzumab deruxtecan (T-DXd) compared with investigator's choice chemotherapy in terms of PFS by BICR in the HR+, HER2-low (IHC 2+/ISH- and IHC 1+) populations.Read full original descriptionShow less
A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)
To assess the efficacy of Trastuzumab deruxtecan (T-DXd) compared with investigator's choice chemotherapy in terms of PFS by BICR in the HR+, HER2-low (IHC 2+/ISH- and IHC 1+) populations.
Inclusion: Patients must be ≥18 years of age; Pathologically documented breast cancer that: a. is advanced or metastatic b. Has a history of HER2-low or negative expression, defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or IHC 0 (ISH- or untested) c. Has HER2-low expression or HER2 IHC >0 <1+ expression as determined by the central laboratory result from a metastatic setting d. was never previously HER2-positive e. has documented HR+ disease in the metastatic disease setting; Has adequate tumor samples for assessment of HER2 status; Disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy (Progression of disease within 24 months on adjuvant ET is considered a line of therapy) or disease progression on endocrine therapy + CDK4/6 inhibitor within 6 months of starting first line treatment for metastatic disease and considered appropriate for chemotherapy as the next treatment by the investigator; No prior chemotherapy for advanced or metastatic breast cancer; Has protocol-defined adequate organ and bone marrow function. The most recent results must be used to meet this inclusion criteria.
Exclusion: Ineligible for all options in the investigator's choice chemotherapy arm. Patients with contraindications to capecitabine, paclitaxel, and nabpaclitaxel treatment, per local prescribing information, cannot be enrolled; Active or prior documented ILD/pneumonitis that required steroids or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening; Concurrent enrolment in another clinical study, unless it is: - an observational (non-interventional) clinical study - during the follow up period of a prior interventional study (prescreening for this study while a patient is on treatment in another clinical study is acceptable); Have received a study treatment from a prior interventional study, administered in the last 30 days prior to first dose of this study treatment; Uncontrolled intercurrent illness or significant cardiovascular disease; Lung-specific intercurrent clinically significant illnesses; Patients with spinal cord compression or active clinically central nervous system metastasis.