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

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

Summary

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

Description

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

Conditions

Breast Tumors

Intervention

DS-8201a

Location

Institut de Cancérologie de l'Ouest - Site Paul Papin
Angers
France

Status

Not yet recruiting

Source

UNICANCER

Results (where available)

View Results

Links

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

Clinical Trials [3764 Associated Clinical Trials listed on BioPortfolio]

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer

Some HER-2 breast cancer patients do not respond or build resistance to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has no...

Phase 1 Study of DS-8201a in HER-2 Breast Cancer Patients

This study will look at the effect of DS-8201a on heart rate and the movement of the drug through the body (pharmacokinetics) in participants with a certain type of breast cancer (HER2).

DS-8201a Compared to Treatment of Physician's Choice for Participants With a Certain Kind of Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04]

The reason for this trial is to compare DS-8201a to other treatments being used for breast cancer. DS-8201a is a new medicine for breast cancer that has not been approved yet by the Food ...

Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors

This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.

Study of DS-8201a for Participants With Advanced Solid Malignant Tumors

HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells. This study will...

PubMed Articles [5933 Associated PubMed Articles listed on BioPortfolio]

Serum levels of Organochlorine Pesticides and Breast Cancer Risk in Iranian Women.

Breast cancer is a multifactorial disease and its etiology is linked to multiple risk factors. There are shreds of controversial evidence that exposure to organochlorine pesticides (OCPs) are importan...

Management trends and outcomes of breast angiosarcoma: Is breast conservation feasible?

We queried the National Cancer Database for nonmetastatic breast angiosarcoma, yielding 808 patients (202 de novo, 606 secondary). The median survival was 53.7 months. Secondary tumors were more like...

Novel HER2-Targeting Antibody-Drug Conjugates of Trastuzumab Beyond T-DM1 in Breast Cancer: Trastuzumab Deruxtecan(DS-8201a) and (Vic-)Trastuzumab Duocarmazine (SYD985).

Targeted drug delivery has improved cancer treatment significantly in recent years, although it is difficult to achieve. Different approaches have been developed to apply targeted drug delivery. Among...

A targeted mass spectrometry immunoassay to quantify osteopontin in fresh-frozen breast tumors and adjacent normal breast tissues.

Osteopontin (OPN) is a multifunctional protein that can activate cell-signaling pathways and lead to cancer development and metastasis. Elevated OPN expression was reported in different cancer types, ...

Consideration of breast cancer subtype in targeting the androgen receptor.

The androgen receptor (AR) is a drug target in breast cancer, and AR-targeted therapies have induced tumor responses in breast cancer patients. In this review, we summarized the role of AR in breast c...

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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