Trial · NCT02299635
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response (OR) Rate in Participants With Advanced Triple Receptor-Negative Breast Cancer (mTNBC) Harboring Activating Genomic Alterations in Notch Receptors (NA+) | Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first. | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | OR Rate in Participants With mTNBC Whose Tumors Tested Negative for Eenomic Alterations in Notch Receptor (NA-) | Cycle 3 Day 1, Cycle 5 Day 1, and every 6 weeks for subsequent cycles ntil disease progression, patient refusal for further follow up, or start of another anti-cancer treatment, whichever occurred first. | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC | 2 years | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | Duration of Response (DR) in Participants With NA+ or NA mTNBC | 2 years | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | One-Year Survival Probability in Participants With NA+ or NA mTNBC | 1 year | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | Overall Survival (OS) in Participants With NA+ or NA mTNBC | 2 years | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | Type of Notch Genomic Alterations in Participants With NA+ mTNBC | 2 years | Data for this outcome measure was not collected due to early termination of this study. | ||
| SECONDARY | Pre-dose Serum Concentration (Ctrough) for PF-03084014 | Day 1 of Cycle 1, 2, 3, and 5 | Due to study termination, no PK analyses were performed for this study. | ||
| SECONDARY | Pharmacodynamic (PD) Effects of PF-03084014 in Tumor Specimens and Peripheral Blood | Day 1 of Cycle 1, 2, 3, and 5 | Due to study termination, no PD analyses were performed for this study. | ||
| SECONDARY | Alterations in Genes, Proteins, and RNAs Relevant to the Notch Signaling Pathway, to TNBC Biology, and to Sensitivity/Resistance to PF-03084014 in Tumor Specimens and Peripheral Blood. | Day 1 of Cycle 1, 2, 3, and 5 | Due to study termination, no PD analyses were performed for this study. | ||
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | 2 years | The safety analysis set included all enrolled participants who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent AEs by CTCAE Grade | 2 years | The safety analysis set included all enrolled participants who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test (Hematology) Abnormalities | Day 1 of Cycles 1, 2, 3, 4, 5, and subsequent cycles. | The safety analysis set included all enrolled participants who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test (Chemistry) Abnormalities | Day 1 and Day 15 of Cycles 1, 2, 3, 4, 5, and subsequent cycles up to Cycle 8 and Day 8 of Cycle 1 | The safety analysis set included all enrolled participants who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Participants With Laboratory Test (Urinalysis) Abnormalities | Day 1 of Cycle 1 | The safety analysis set included all enrolled participants who received at least one dose of study medication. | participants | NUMBER |
| SECONDARY | Number of Notch Genomic Alterations in Participants With NA+ mTNBC | 2 years | Data for this outcome measure was not collected due to early termination of this study. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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