Trial · NCT02299635
A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
NCT02299635, Phase 2, Terminated, Pfizer; results first posted 2017-01-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations. Trials, record NCT02299635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02299635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating PF-03084014 In Patients With Advanced Breast Cancer With Or Without Notch Alterations
- NCT number
- NCT02299635
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 19 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Triple Negative Breast Neoplasms
- Interventions
- PF-03084014, PF-03084014, PF-03084014
- First posted
- 2014-11-24
- Last updated
- 2019-01-08
- Other registries' IDs
- eudract:2014-002286-30
- Results first posted
- 2017-01-13
- Limitations and caveats
- This study was terminated prematurely based on project re-prioritization by the Sponsor and was not due to any safety concerns or regulatory actions.
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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. | OR status based on assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis less than \[\<\]10 millimeter \[mm\]). PR: Greater than or equal to (\>=)30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR. |
| 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. | OR status based on assessment of confirmed CR or confirmed PR according to RECIST 1.1. CR: Complete disappearance of all target lesions with the exception of nodal disease and all target nodes decreased to normal size (short axis \<10 mm). PR: \>=30% decrease under baseline of the sum of diameters of all target measurable lesions. OR=CR+PR. |
| Secondary | Progression-Free Survival (PFS) in Participants With NA+ or NA mTNBC | 2 years | The period from study entry until disease progression, death, whichever occurred first as per RECIST version 1.1. |
| Secondary | Duration of Response (DR) in Participants With NA+ or NA mTNBC | 2 years | Time from the first documentation of objective tumor response to objective tumor progression or death due to any cause. DR was calculated for the subgroup of patients with a confirmed objective tumor response. Objective Progression (PD): 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm. |
| Secondary | One-Year Survival Probability in Participants With NA+ or NA mTNBC | 1 year | Overall survival (OS) status (alive or not) at 1 year after study entry. The the survival probability at 1 year was summarized as a product limit estimator based on the Kaplan-Meier method to account for censored events. |
| Secondary | Overall Survival (OS) in Participants With NA+ or NA mTNBC | 2 years | OS was the duration from enrollment to death. For participants who are alive, overall survival was censored at the last contact. |
| Secondary | Type of Notch Genomic Alterations in Participants With NA+ mTNBC | 2 years | Type of notch genomic alterations identified by NGS assay in patients with NA+ mTNBC |
| Secondary | Pre-dose Serum Concentration (Ctrough) for PF-03084014 | Day 1 of Cycle 1, 2, 3, and 5 | |
| Secondary | Pharmacodynamic (PD) Effects of PF-03084014 in Tumor Specimens and Peripheral Blood | Day 1 of Cycle 1, 2, 3, and 5 | Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes. |
| 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 | Original diagnostic tumor tissue or the most recent metastatic tumor (archival or de novo biopsy), plasma, and peripheral blood samples were collected for biomarker assessments of circulating analytes, immunohistochemistry for notch receptors expression, expression of notch pathway components and modulators, mutational analysis of pathway and disease associated genes. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | PF-03084014 | Number of Participants with AEs | 18 | participants | |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) | PF-03084014 | Number of Participants with SAEs | 6 | participants | |
| Number of Participants With Treatment-Emergent AEs by CTCAE Grade | PF-03084014 | Any AEs, Grade 1 | 1 | participants | |
| Number of Participants With Treatment-Emergent AEs by CTCAE Grade | PF-03084014 | Any AEs, Grade 2 | 5 | participants | |
| Number of Participants With Treatment-Emergent AEs by CTCAE Grade | PF-03084014 | Any AEs, Grade 3 | 9 | participants | |
| Number of Participants With Treatment-Emergent AEs by CTCAE Grade | PF-03084014 | Any AEs, Grade 4 | 1 | participants | |
| Number of Participants With Treatment-Emergent AEs by CTCAE Grade | PF-03084014 | Any AEs, Grade 5 | 2 | participants | |
| Number of Participants With Laboratory Test (Hematology) Abnormalities | PF-03084014 | Anemia | 12 | participants | |
| Number of Participants With Laboratory Test (Hematology) Abnormalities | PF-03084014 | Lymphocyte count increased | 0 | participants | |
| Number of Participants With Laboratory Test (Hematology) Abnormalities | PF-03084014 | Lymphopenia | 11 | participants |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PF-03084014 | 19 | |
| Overall Study | COMPLETED | PF-03084014 | 0 | |
| Overall Study | NOT COMPLETED | PF-03084014 | 19 |
Source ClinicalTrials.gov
Adverse events81
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | PF-03084014 | 1 | 19 | |
| other | Angina pectoris | Cardiac disorders | PF-03084014 | 1 | 19 | |
| other | Vertigo | Ear and labyrinth disorders | PF-03084014 | 1 | 19 | |
| other | Eye discharge | Eye disorders | PF-03084014 | 1 | 19 | |
| other | Photopsia | Eye disorders | PF-03084014 | 1 | 19 | |
| other | Vitreous floaters | Eye disorders | PF-03084014 | 1 | 19 | |
| other | Abdominal pain | Gastrointestinal disorders | PF-03084014 | 1 | 19 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PF-03084014 | 1 | 19 | |
| other | Diarrhoea | Gastrointestinal disorders | PF-03084014 | 11 | 19 | |
| other | Dry mouth | Gastrointestinal disorders | PF-03084014 | 2 | 19 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PF-03084014 | ||
| Total, other adverse events | PF-03084014 | 18 | 19 |
| Total, serious adverse events | PF-03084014 | 6 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02299635
GET https://conductscience.org/api/trials/v1/NCT02299635/results?page=2