Trial · NCT02907918
Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
NCT02907918, Phase 2, Terminated, Washington University School of Medicine; results first posted 2021-09-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer. Trials, record NCT02907918. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02907918
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast Cancer
- NCT number
- NCT02907918
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Breast Cancer, Cancer of Breast, Breast Carcinoma
- Interventions
Palbociclib, Letrozole, Trastuzumab, Goserelin, Breast surgery, Research tumor biopsy, Research bone marrow (OPTIONAL), Research blood sample, Research blood for germline DNA, Blood for detection of circulating tumor cells
- First posted
- 2016-09-20
- Last updated
- 2021-09-29
- Results first posted
- 2021-09-05
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Pathologic Complete Response (pCR) | Completion of 4 cycles of treatment (approximately 16 weeks) | A pathologic complete response (pCR) is defined as no histology evidence of invasive tumor cells in the surgical breast specimen and sentinel or axillary lymph nodes. |
| Secondary | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | 30 days after completion of neoadjuvant therapy (approximately 21 weeks) | -The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting. |
| Secondary | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks) | * Answers ranging from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) * PRO-CTCAE responses are scored from 0 to 4, and there are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. * PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively |
Source ClinicalTrials.gov
Outcomes3
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 Pathologic Complete Response (pCR) | Completion of 4 cycles of treatment (approximately 16 weeks) | One participant is not evaluable for this outcome measure because the participant experienced progressive disease after completion of treatment but prior to surgery. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | 30 days after completion of neoadjuvant therapy (approximately 21 weeks) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change in Patient Reported Outcomes as Measured by NCI PRO-CTCAE | Baseline, cycle 2 day 1 (approximately 29 days), and end of cycle 4 (approximately 16 weeks) | 3 participants at the end of cycle 4 did not complete the questionnaire. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group66
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 Pathologic Complete Response (pCR) | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 2 | Participants | ||
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Neutrophil count decreased | 13 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Lymphocyte count decreased | 1 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Hypertension | 8 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | White blood cell decreased | 2 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Colitis | 1 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Hypokalemia | 1 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Pulmonary edema | 1 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Ventricular tachycardia | 1 | Participants | |
| Safety and Tolerability of Palbociclib in Combination With Neoadjuvant Letrozole and Trastuzumab (or FDA Approved Biosimilar) as Measured by Number of Participants With Grade 3 & 4 Adverse Events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | Alanine aminotransferase increased | 1 | Participants |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 26 | |
| Overall Study | COMPLETED | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 26 | |
| Overall Study | NOT COMPLETED | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 0 |
Source ClinicalTrials.gov
Adverse events117
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 | Anemia | Blood and lymphatic system disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 20 | 26 | |
| other | Intravenous antibiotics for positive blood cultures | Blood and lymphatic system disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 1 | 26 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 1 | 26 | |
| other | Palpitations | Cardiac disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 2 | 26 | |
| other | Ventricular tachycardia | Cardiac disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 1 | 26 | |
| other | Blurred vision | Eye disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 3 | 26 | |
| other | Depth perception change | Eye disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 1 | 26 | |
| other | Dry eye | Eye disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 3 | 26 | |
| other | Stye - left eye | Eye disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 1 | 26 | |
| other | Watering eyes | Eye disorders | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 1 | 26 |
1 to 10 of 117Source ClinicalTrials.gov
See all 117 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 0 | 26 |
| Total, other adverse events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 26 | 26 |
| Total, serious adverse events | Palbociclib + Letrozole + Trastuzumab +/- Goserelin | 2 | 26 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36609389 | DERIVED |
Source PubMed
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/NCT02907918
GET https://conductscience.org/api/trials/v1/NCT02907918/results?page=2