Trial · NCT01973660
PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer
NCT01973660, Phase 2, Completed, SOLTI Breast Cancer Research Group
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer. Trials, record NCT01973660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01973660
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PAM50 HER2-enriched Phenotype as a Predictor of Response to Dual HER2 Blockade in HER2-positive Early Breast Cancer
- NCT number
- NCT01973660
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Conditions
- Breast Cancer
- Interventions
- Lapatinib, Trastuzumab, Endocrine Therapy, Paclitaxel
- First posted
- 2013-10-31
- Last updated
- 2018-09-19
- Other registries' IDs
- eudract:2013-001036-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | pCRB to dual HER2 blockade with lapatinib and trastuzumab in all patients, at the time of surgery, predicted by PAM50 HER2-E subtype | At the time of surgery | Comparison between the PAM50 HER2-E versus non HER2-E cases to achieve pCRB from dual HER2 blockade with lapatinib and trastuzumab at the time of surgery |
| Secondary | Pathological complete response in the breast and axilla (pCRBL) to dual HER2 blockade with lapatinib and trastuzumab, in all patients, at the time of surgery, predicted by PAM50 HER2-E subtype | At the time of surgery | Comparison between the PAM50 HER2-E versus non HER2-E cases to achieve pCRBL from dual HER2 blockade with lapatinib and trastuzumab at the time of surgery |
| Secondary | Residual cancer burden in the breast (RCB) to dual HER2 blockade with lapatinib and trastuzumab, in all patients, at the time of surgery, predicted by PAM50 HER2-E subtype | At the time of surgery | Correlation between PAM50 HER2-E cases and RCB status (0-I versus II-III) after dual HER2 blockade with lapatinib and trastuzumab at the time of surgery |
| Secondary | Changes in the percentage of Ki67-positive cells in PAM50 non-Luminal A/B (combined) subtypes | Day 14 | Comparison of the changes in the percentage of Ki67-positive cells in Luminal versus non-Luminal subtypes after 14 days of dual HER2 blockade plus endocrine therapy |
| Secondary | Gene expression variations in all patients, in HR-negative and in HR-positive patients | Day 14 | Compare significant changes in gene expression from baseline to Day 14 in the entire study population and separately, in the HR-negative and HR-positive patients |
| Secondary | Correlation between PAM50 HER2-E centroid, as a continuous variable, and pCR and/or RCB in the breast to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery | At the time of surgery | |
| Secondary | Identification of additional gene expression signatures beyond the PAM50 subtypes that predict pCR and/or RCB to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery | At the time of surgery | In all patients and in those with HR-positive and HR-negative disease |
| Secondary | PAM50 risk of relapse (ROR) score and its ability to predict pCR and/or RCB in the breast to dual HER2 blockade with lapatinib and trastuzumab at the time of surgery in all patients and in those with HR-positive and HR-negative disease | At the time of surgery | Correlation between the PAM50 ROR and pCR and/or RCB after dual HER2 blockade with lapatinib and trastuzumab at the time of surgery |
| Secondary | PAM50 HER-2 subtype (PAM50 HER2-E signature) ability as a continuous variable to predict pCRB to dual HER2 blockade at the time of surgery in patients with HR-positive disease and in patients with HR-negative disease | At the time of surgery | |
| Secondary | Changes in gene expression from day 0 to day 14, after dual HER2 blockade, that predict pCRB in all patients and in those with HR-positive and HR-negative disease | Day 14 | Identification of gene expression changes that correlate with pCRB or RCB after dual HER2 blockade treatment |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 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.
Papers7
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 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/NCT01973660
GET https://conductscience.org/api/trials/v1/NCT01973660/registered