Trial · NCT07386938
A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
NCT07386938, Phase 3, Active not recruiting, R-Pharm
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer. Trials, record NCT07386938. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07386938
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy, Safety and Pharmacokinetics of RPH-051 and Perjeta® in Combination With Trastuzumab and Docetaxel as the 1st Line Therapy in Patients With HER2-positive Breast Cancer
- NCT number
- NCT07386938
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 246 participants, estimated
- Lead sponsor
- R-Pharm
- Conditions
- Locally Advanced Breast Cancer, Metastatic Breast Cancer
- Interventions
- RPH-051, Docetaxel, Perjeta®, Trastuzumab
- First posted
- 2026-02-04
- Last updated
- 2026-07-14
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective response rate (%) (ORR) | Up to day 126 | Objective response rate (%) (ORR) for a period of up to 18 weeks of therapy inclusive. ORR is the percentage of patients in a group achieving either a complete or partial tumor response to therapy. Complete Response (CR) is the disappearance of all target lesions confirmed by the computer tomography (CT) for at least 4 weeks; the short axis of any previously pathological lymph node (target or non-target) must be \< 10 mm. Partial Response (PR) is at least a 30% reduction in the sum of diameters of target lesions, maintained for at least 4 weeks compared with baseline (screening) values |
| Secondary | Disease control rate (DCR) (%) | Up to day 126 | Disease control rate (DCR) (%) for a period of up to 18 weeks of therapy inclusive. DCR is the percentage of patients in a group achieving a complete or partial tumor response to therapy, or disease stabilization. Stable Disease (SD) is defined as neither a sufficient decrease in the sum of diameters of target lesions to qualify as a partial response, nor an increase in the sum of diameters that would be considered disease progression, compared with the smallest sum of diameters recorded during the observation period |
| Secondary | Time to tumor response to therapy (TTR) | Up to day 126 | Time to tumor response to therapy (TTR) for a period of up to 18 weeks of therapy inclusive. TTR is the time from the start of the study therapy to the first documented objective tumor response |
| Secondary | Duration of tumor response to therapy (DOR) | Up to day 126 | Duration of tumor response to therapy (DOR) for a period of up to 18 weeks of therapy inclusive. DOR is the time from the first documented objective tumor response to disease progression or death from any cause. Progression (PD) is defined as a ≥20% increase in the sum of diameters of target lesions compared with the smallest sum recorded during the observation period (with an absolute increase of at least 5 mm), or the appearance of one or more new lesions |
| Secondary | Progression-free survival (PFS) expressed as PFS level (%) | Up to day 126 | Progression-free survival (PFS) expressed as PFS level (%) for a period of up to 18 weeks of therapy inclusive |
| Secondary | Progression-free survival (PFS) expressed as median PFS | Up to day 126 | Progression-free survival (PFS) expressed as median PFS for a period of up to 18 weeks of therapy inclusive |
| Secondary | Area under the pharmacokinetic curve "concentration-time" (AUC(0-504)) of pertuzumab | Pre-dose on Day 1 (first administration) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (Day 2), 96 (Day 5), 216 (Day 10), 336 (Day 15), 504 (Day 22) hours post-dose | Area under the pharmacokinetic curve "concentration-time" of pertuzumab after the first (single dose) administration, truncated at the point before the second administration, i.e. up to 504 hours |
| Secondary | Maximum serum concentration of pertuzumab after the first administration (Cmax) | Pre-dose on Day 1 (first administration) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (Day 2), 96 (Day 5), 216 (Day 10), 336 (Day 15), 504 (Day 22) hours post-dose | Maximum serum concentration of pertuzumab after the first administration (Cmax) |
| Secondary | Maximum serum concentration of pertuzumab at steady state (Cmax ss) after the 3rd administration | Pre-dose on Day 43 (+2 days, third infusion) and 1, 1.5, 2, 2.5, 4, 7, 12 hours post-dose; 24 (+72 h, Day 44 +2), 96 (+72 h, Day 47 +2), 216 (+72 h, Day 52 +2), 336 (+72 h, Day 57 +2), 504 (+72 h, Day 64 +2) hours post-dose | Maximum serum concentration of pertuzumab at steady state (Cmax ss) after the 3rd administration |
| Secondary | Minimum serum concentration of pertuzumab at steady state (Cmin ss) after the 3rd administration | Pre-dose immediately before the second, third (Day 43 +2), fourth, fifth (Day 85 +2), and sixth (Day 106 +2) infusions (≤ 30 minutes before administration) | Minimum serum concentration of pertuzumab at steady state (Cmin ss) after the 3rd administration |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT07386938
GET https://conductscience.org/api/trials/v1/NCT07386938/registered?page=2