Trial · NCT01306942
Dasatinib In Combination With Trastuzumab And Paclitaxel In First Line Treatment Of Her2-Positive MBC Patients
NCT01306942, Phase 1, Phase 2, Completed, Spanish Breast Cancer Research Group; results first posted 2019-09-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Dasatinib In Combination With Trastuzumab And Paclitaxel In First Line Treatment Of Her2-Positive MBC Patients. Trials, record NCT01306942. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01306942
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dasatinib In Combination With Trastuzumab And Paclitaxel In First Line Treatment Of Her2-Positive MBC Patients
- NCT number
- NCT01306942
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Spanish Breast Cancer Research Group
- Conditions
- Metastatic Breast Cancer
- Interventions
- Dasatinib, Trastuzumab, Paclitaxel
- First posted
- 2011-03-02
- Last updated
- 2023-03-30
- Other registries' IDs
- eudract:2010-023304-27
- Results first posted
- 2019-09-09
Source ClinicalTrials.gov
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Up to cycle 1 | DLT was defined as the occurrence of any of the following adverse events or abnormal laboratory value (graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03), assessed as possibly, probably or definitively related to study drugs, occurring within the first cycle of study treatment: Need of any dose modification within the first cycle due to toxicity, grade 3 or 4 neutropenia complicated with fever ≥38.5° C or infection, grade 4 neutropenia (absolute neutrophil count (ANC)\<0.5x1000000000/L) of at least 7 days duration, grade 3 thrombocytopenia complicated by hemorrhage, grade 4 thrombocytopenia, any grade 4 non-hematologic toxicity, grade 3 non-hematologic toxicities except nausea, vomiting, or diarrhea that can be controlled by appropriate medical intervention or prophylaxis, inability to resume dosing for cycle 2 at the current dose level within 14 days due to treatment related toxicity. |
| Primary | Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Up to cycle 1 | MTD is determined by testing increasing doses of dasatinib on dose escalation cohorts 3 to 6 patients per dose level. MTD reflects the highest dose tested in which a DLT is experienced by 0 out of 3 or 1 out of 6 patients among the dose levels |
| Primary | Recommended Phase II Dose (RP2D) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I). | Up to cycle 1 | The RP2D was decided by the investigators taken into consideration the information obtained in the study and based on the MTD. To define the RP2D, information about toxicity observed during the full treatment were taken into consideration (relative dose intensity and toxicity observed). |
| Primary | Objective Response Rate (ORR) | Through study treatment, an average of 24 months | Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. ORR is defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) out of the patients who had measurable disease at baseline. Per RECIST, Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as an \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | The Number of Participants Who Experienced Adverse Events (AE) | Through study treatment, an average of 24 months | Safety was assessed by standard clinical (blood pressure, pulse and body temperature, electrocardiogram (ECG), left ventricular ejection fraction (LVEF)) and laboratory tests (hematology: hemoglobin, platelet count, red blood cells (RBC), white blood cells (WBC) with differential (neutrophils) and absolute lymphocyte count, and serum chemistry: alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin, creatinine, sodium, potassium, magnesium, phosphate and calcium). Adverse events grade were defined by the NCI CTCAE v 4.03. |
| Secondary | To Evaluate the Clinical Benefit Rate (CBR) | Through study treatment, an average of 24 months | Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. CBR is defined as the percentage of patients with a Complete Response (CR) or Partial Response (PR) plus stable disease lasting at least 6 months out of the efficacy population. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Time to Progression (TTP) | Through study treatment, an average of 24 months | TTP is defined as the time from the date of the first dose to the first date of objectively determined progressive disease. For patients not known to have objectively-determined progressive disease, TTP will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression, TTP will be censored at the date of last objective progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. |
| Secondary | Progression Free Survival (PFS) | Through study treatment, an average of 24 months | PFS is defined as the time from the date of the first dose to the first date of objectively determined progressive disease or death from any cause. For patients not known to have died as of the data cut-off date and who do not have objectively-determined progressive disease, PFS will be censored at the date of the last objective progression-free assessment. For patients who receive subsequent systemic anticancer therapy (after discontinuation from the study treatment) prior to objective disease progression or death, PFS will be censored at the date of last objective progression-free assessment prior to the initiation of post-discontinuation systemic anticancer therapy. |
| Secondary | Response Duration (RD) | Through study treatment, an average of 24 months | Tumor response was assessed using Response Evaluation Criteria In Solid Tumors Criteria (RECIST 1.1) criteria. RD is defined as the time from the date when the measurement criteria are met for complete response (CR) or partial response (PR) (whichever status is recorded first) until the date of first observation of disease progression or death occurred. Per RECIST, CR is defined as the disappearance of all target lesions; PR is defined as an \>=30% decrease in the sum of the longest diameter of target lesions. For responding patients not known to have died as of the data cut-off date and who do not have progression, RD will be censored at the date of last visit with adequate assessment. For responding patients who receive subsequent anticancer therapy (after discontinuation from the study treatment) prior to progression, RD will be censored at the date of last visit with adequate assessment prior to the initiation of post-discontinuation anticancer therapy. |
| Secondary | Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Cycle 1 day 2 and day 18 | To assess the influence of the concomitant administration of paclitaxel and trastuzumab on dasatinib PKs, we compared dasatinib exposures alone (first PK occasion: day 2 of cycle 1) or combined (second PK occasion: day 18 on cycle 1). The mean profiles of dasatinib plasma concentrations were determined by dose and PK occasion. |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Up to cycle 1 | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Up to cycle 1 | mg | NUMBER | |
| PRIMARY | Recommended Phase II Dose (RP2D) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I). | Up to cycle 1 | mg | NUMBER | |
| PRIMARY | Objective Response Rate (ORR) | Through study treatment, an average of 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | The Number of Participants Who Experienced Adverse Events (AE) | Through study treatment, an average of 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | To Evaluate the Clinical Benefit Rate (CBR) | Through study treatment, an average of 24 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Progression (TTP) | Through study treatment, an average of 24 months | months | MEDIAN | |
| SECONDARY | Progression Free Survival (PFS) | Through study treatment, an average of 24 months | months | MEDIAN | |
| SECONDARY | Response Duration (RD) | Through study treatment, an average of 24 months | months | MEDIAN | |
| SECONDARY | Dasatinib Maximun Plasma Concentration (Cmax) Value (Pharmacokinetics (PK) Phase I) | Cycle 1 day 2 and day 18 | Two participant samples for cycle 1 day 18 could not be obtained. | ng/mL | MEAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group43
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 Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 1 | Participants | ||
| Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 2 | Participants | ||
| Maximum Tolerated Dose (MTD) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) | Phase I: Dasatinib + Trastuzumab + Paclitaxel | 100 | mg | ||
| Recommended Phase II Dose (RP2D) of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I). | Phase I: Dasatinib + Trastuzumab + Paclitaxel | 100 | mg | ||
| Objective Response Rate (ORR) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 23 | Participants | ||
| The Number of Participants Who Experienced Adverse Events (AE) | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 6 | Participants | ||
| The Number of Participants Who Experienced Adverse Events (AE) | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 4 | Participants | ||
| The Number of Participants Who Experienced Adverse Events (AE) | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 29 | Participants | ||
| To Evaluate the Clinical Benefit Rate (CBR) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 24 | Participants | ||
| Time to Progression (TTP) | Phase II:Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 23.9 | 95% Confidence Interval 14.9 to NA | months |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase I | STARTED | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 6 | |
| Phase I | STARTED | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 4 | |
| Phase I | STARTED | Dasatinib 70mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | |
| Phase I | STARTED | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 0 | |
| Phase I | COMPLETED | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 1 | |
| Phase I | COMPLETED | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 1 | |
| Phase I | COMPLETED | Dasatinib 70mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | |
| Phase I | COMPLETED | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 0 | |
| Phase I | NOT COMPLETED | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 5 | |
| Phase I | NOT COMPLETED | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events165
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 | Alanine aminotransferase increased | Investigations | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 1 | 6 | |
| other | Alanine aminotransferase increased | Investigations | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | 4 | |
| other | Alanine aminotransferase increased | Investigations | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 0 | 29 | |
| other | Aspartate aminotransferase increased | Investigations | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 1 | 6 | |
| other | Aspartate aminotransferase increased | Investigations | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | 4 | 0 |
| other | Aspartate aminotransferase increased | Investigations | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 0 | 29 | |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 2 | 6 | |
| other | Diarrhea | Gastrointestinal disorders | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 1 | 29 | |
| other | Fatigue | General disorders | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 1 | 6 |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | 6 |
| Total, all-cause mortality | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 0 | 4 |
| Total, all-cause mortality | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 1 | 29 |
| Total, other adverse events | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 6 | 6 |
| Total, other adverse events | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 4 | 4 |
| Total, other adverse events | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 29 | 29 |
| Total, serious adverse events | Dasatinib 100mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 1 | 6 |
| Total, serious adverse events | Dasatinib 140mg + Trastuzumab 2mg/kg + Paclitaxel 80mg/m2 | 2 | 4 |
| Total, serious adverse events | PhaseII Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 | 6 | 29 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Phase I: Dasatinib 100mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2 vs Phase I: Dasatinib 140mg/Trastuzumab 2mg/kg/Paclitaxel 80mg/m2: Number of Participants With Dose Limiting Toxicity (DLT) Within the First Cycle of Dasatinib in Combination With Trastuzumab and Paclitaxel (Phase I) |
Source Trial comparisons
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/NCT01306942
GET https://conductscience.org/api/trials/v1/NCT01306942/results?page=2