Data

A randomised phase III trial of adjuvant radiation therapy versus observation following breast conserving surgery and endocrine therapy in patients with molecularly characterised luminal A early breast cancer (BCT 2102: TUGETHER)..

Breast Cancer Trials (BCT)

Dataset description

THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 57 participants, male or femal >= 18 years with HER2 positive unresectable loco-regional or metastatic breast cancer. PD-L1 and TILs status recorded at pre-registration. Participants receive tucatinib 300mg Day 1-21 of each 21 day cycle + Pembrolizumab 200mg Day 1 of each 21 day cycle + Trastuzumab 6mg/kg Day 1 of each 21 day cycle. Treatment continues until disease progression or unacceptable toxicity. Participants who stop treatment for reasons other than progressive disease/new anti-cancer therapy will have clinical follow up vivists every 6 weeks for 24 weeks, then every 9 weeks. Participants who stop treatment due to progressive disease due to progressive disease /new anti-cancer therapy will have Survival Follow Up every 4 months. The primary endpoint is objective response rate per RECIST 1.1 in the PD-L1 positive cohort, as devined by the 22C3 pharmDx PD-L1 assay of immune cell positivity of >= 10.
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Subjects

Chemotherapy |

Source Study

Trial acronym

Not available

Trial ID

NCT04789096

Purpose

Not available

Phase

Not available

Funding

Not available

Scientific enquiries

Not available

Brief Summary

Women or men with HER2-positive, metastatic breast cancer, who have progressed on previous treatment, will receive tucatinib in combination with pembrolizumab and trastuzumab (PD-L1 positive).

Key Inclusion Criteria

Inclusion Criteria (Pre-Registration): 1. Has provided written, informed consent to participate in the study. 2. Female or male, age = 18 years. 3. Local histologically confirmed HER2-positive unresectable loco-regional or metastatic breast cancer. HER2-positive according to ASCO CAP 2018 guidelines defined as: 1. ISH testing with ERBB2-amplification as demonstrated by ratio ERBB2/centromeres = 2.0 or mean gene copy number = 6 OR 2. 3+ staining by IHC. 4. FFPE tumour samples (preferably two bloc ....
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Key Exclusion Criteria

Can healthy volunteers participate?

No

 

Population

Sample Size    Not Available

Min. age    18 Years

Max. age    N/A

Sex    All

Condition category    Not Available

Condition code    Breast Cancer , HER2-positive Breast Cancer

Intervention

Intervention code Treatment: Drugs - Capecitabine , Treatment: Drugs - Pembrolizumab , Treatment: Drugs - Trastuzumab , Treatment: Drugs - Tucatinib

Comparison

Control group Not available

Comparison not available.

Outcomes

Not Available

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the ClinicalTrials.gov. For more information, please see ClinicalTrials.gov