Study of DS-8201a, an Antibody Drug Conjugate for Advanced Breast Cancer Patients, With Biomarkers Analysis

2019-10-24 12:49:29 | BioPortfolio


Multicenter, open-label phase II trial assessing the efficacy of DS-8201a monotherapy in patients with metastatic breast cancer.


The main objective is to evaluate the anti-tumor activity of DS-8201a in three cohorts of advanced breast cancer patients:

- Cohort 1: HER2 over-expressing (HER2 IHC3+ or HER2 IHC2+/ISH+)

- Cohort 2: HER2 low-expressing (IHC1+ or IHC2+/ISH-)

- Cohort 3: HER2 non-expressing (IHC0+)

Study Design


Breast Tumors




Institut de Cancérologie de l'Ouest - Site Paul Papin


Not yet recruiting



Results (where available)

View Results


Published on BioPortfolio: 2019-10-24T12:49:29-0400

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Medical and Biotech [MESH] Definitions

Carbohydrate antigen elevated in patients with tumors of the breast, ovary, lung, and prostate as well as other disorders. The mucin is expressed normally by most glandular epithelia but shows particularly increased expression in the breast at lactation and in malignancy. It is thus an established serum marker for breast cancer.

Tumors or cancer of the human BREAST.

Tumors or cancer found specifically in one human BREAST, but not in both.

A infiltrating (invasive) breast cancer, relatively uncommon, accounting for only 5%-10% of breast tumors in most series. It is often an area of ill-defined thickening in the breast, in contrast to the dominant lump characteristic of ductal carcinoma. It is typically composed of small cells in a linear arrangement with a tendency to grow around ducts and lobules. There is likelihood of axillary nodal involvement with metastasis to meningeal and serosal surfaces. (DeVita Jr et al., Cancer: Principles & Practice of Oncology, 3d ed, p1205)

A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.

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