Adults 18 to 70, female only, with Breast Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Participants Who Had a Tumor Response, According to Standard RECIST (Response Evaluation Criteria in Solid Tumors) CriteriaPrimary· Week 09, Week 18, at the end of each patient's treatment, and at 3, 6, 9, and 12 months after end of treatment.
Those who achieved either complete (disappearance of all target lesions) or partial (at least 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD) response.
Participants who had a complete tumor response
Group
Value
95% CI
Caelyx, Docetaxel, Trastuzumab
2
Participants who had a partial tumor response
Group
Value
95% CI
Caelyx, Docetaxel, Trastuzumab
13
Participants who did not have a tumor response
Group
Value
95% CI
Caelyx, Docetaxel, Trastuzumab
11
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Caelyx, Docetaxel, Trastuzumab
Serious: 6/27 (22%)
Deaths: —
Serious adverse events (12 terms)
Reaction
System
Caelyx, Docetaxel, Trastuz…
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
Skin and subcutaneous tissue disorders
—
NEUTROPENIA
Blood and lymphatic system disorders
—
STOMATITIS
Gastrointestinal disorders
—
VOMITING
Gastrointestinal disorders
—
MUCOSAL INFLAMMATION
General disorders
—
PYREXIA
General disorders
—
SEPSIS
Infections and infestations
—
EJECTION FRACTION DECREASED
Investigations
—
METASTASES TO MENINGES
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
The purpose of this study is to evaluate, in a first stage, the safety (incidence of cardiac toxicity) of Caelyx in combination with Trastuzumab and Docetaxel; and in a second stage, the tumor response rate of this regimen. This study will be conducted in approximately 30 centers. A total of approximately 70 to 95 subjects will be enrolled.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 3 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00687440.