Trial · NCT02623972
A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer
NCT02623972, Phase 2, Active not recruiting, Dana-Farber Cancer Institute; results first posted 2022-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer. Trials, record NCT02623972. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02623972
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer
- NCT number
- NCT02623972
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Inflammatory Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Interventions
- Eribulin, Adriamycin, Cyclophosphamide
- First posted
- 2015-12-08
- Last updated
- 2026-07-06
- Results first posted
- 2022-12-28
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pathologic Complete Response Rate | Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks. | Complete pathologic disease response (pCR) is defined as absence of invasive carcinoma within the breast and axillary lymph nodes following preoperative therapy, based upon pathological assessment of surgical specimens. Those with invasive carcinoma present within the breast and axillary lymph nodes, and participants whose disease is not surgically resectable following preoperative treatment are considered as not having pCR. |
| Secondary | Disease Free Survival | DFS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.The DFS measurement duration is anticipated to last for at least 5 years. | Disease-free survival (DFS) is defined for the participants who undergo surgery, as the duration of time from surgery until ipsilateral local-regional, contralateral or distant invasive recurrence or death from any cause; in the absence of an event, DFS will be censored at the date last know alive and free from recurrence. |
| Secondary | Time to Treatment Failure | TTF is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The TTF measurement duration is anticipated to last for at least 5 years. | Time to treatment failure (TTF) will be defined among all participants, as the duration of time from treatment initiation to a DFS event or progressive disease during preoperative therapy or treatment disease that is not surgically resectable; in the absence of an event, TTF will be censored at the date last know alive and free from recurrence or progression. |
| Secondary | Overall Survival | OS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The OS measurement duration is anticipated to last for at least 5 years. | Overall Survival (OS) will be defined two ways: among patients who undergo surgery, as time from surgery until death from any cause; and among all patients, as the time from treatment initiation until death from any cause. Censoring will use the date last known alive. |
| Secondary | Residual Cancer Burden (RCB) | Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks. | Residual cancer burden is calculated and then categorized based on level of residual disease after neoadjuvant therapy and several other factors as assessed by pathologists. This method uses tumor size, the proportion of that tumor that is invasive carcinoma, the number of axillary lymph nodes containing metastatic carcinoma and the diameter of the largest metastasis in an axillary lymph node. This index is divided into 4 categories: RCB-0, RCB-I, RCB-II, and RCB-III.(RCB category "Unknown" if unable to determine RCB or missing data.) The previous categories are in order of increasing severity of RCB. Measurement of residual breast cancer burden can predict survival after neoadjuvant chemotherapy. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pathologic Complete Response Rate | Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such up to 20 weeks. | percentage of participants | NUMBER | |
| SECONDARY | Disease Free Survival | DFS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death.The DFS measurement duration is anticipated to last for at least 5 years. | |||
| SECONDARY | Time to Treatment Failure | TTF is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The TTF measurement duration is anticipated to last for at least 5 years. | |||
| SECONDARY | Overall Survival | OS is assessed every cycle for 8 cycles. After protocol therapy, assessed every 3 months for 1 year, then every 6 months for 4 years, then annually until death. The OS measurement duration is anticipated to last for at least 5 years. | |||
| SECONDARY | Residual Cancer Burden (RCB) | Assessed after preoperative therapy with either 4 cycles of eribulin mesylate (3 wks) followed by 4 cycles of doxorubicin/cyclophosphamide (2 wks) or after 4 cycles of AC(2 wks) followed by 4 cycles of eribulin(3 wks). As such summed up to 20 weeks. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Pathologic Complete Response Rate | Arm A: Eribulin followed by AC | 6.25 | 80% Confidence Interval 0.66 to 22.22 | percentage of participants | |
| Pathologic Complete Response Rate | Arm B: AC followed by Eribulin | 0 | 80% Confidence Interval 0 to 31.87 | percentage of participants | |
| Residual Cancer Burden (RCB) | Arm A: Eribulin followed by AC | RCB-0 | 6.25 | 80% Confidence Interval 0.66 to 22.22 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm B: AC followed by Eribulin | RCB-0 | 0 | 80% Confidence Interval 0 to 31.87 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm A: Eribulin followed by AC | RCB-I | 12.5 | 80% Confidence Interval 3.37 to 29.96 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm B: AC followed by Eribulin | RCB-I | 0 | 80% Confidence Interval 0 to 31.87 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm A: Eribulin followed by AC | RCB-II | 25 | 80% Confidence Interval 11.38 to 43.89 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm B: AC followed by Eribulin | RCB-II | 50 | 80% Confidence Interval 20.09 to 79.91 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm A: Eribulin followed by AC | RCB-III | 56.25 | 80% Confidence Interval 37.5 to 73.71 | percentage of participants |
| Residual Cancer Burden (RCB) | Arm B: AC followed by Eribulin | RCB-III | 33.33 | 80% Confidence Interval 9.26 to 66.68 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A: Eribulin followed by AC | 16 | |
| Overall Study | STARTED | Arm B: AC followed by Eribulin | 6 | |
| Overall Study | COMPLETED | Arm A: Eribulin followed by AC | 16 | |
| Overall Study | COMPLETED | Arm B: AC followed by Eribulin | 6 | |
| Overall Study | NOT COMPLETED | Arm A: Eribulin followed by AC | 0 | |
| Overall Study | NOT COMPLETED | Arm B: AC followed by Eribulin | 0 |
Source ClinicalTrials.gov
Adverse events160
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 | Arm A: Eribulin followed by AC | 2 | 16 | |
| other | Anemia | Blood and lymphatic system disorders | Arm B: AC followed by Eribulin | 0 | 6 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Arm A: Eribulin followed by AC | 0 | 16 | |
| other | Lymph node pain | Blood and lymphatic system disorders | Arm B: AC followed by Eribulin | 1 | 6 | |
| other | Palpitations | Cardiac disorders | Arm A: Eribulin followed by AC | 1 | 16 | |
| other | Palpitations | Cardiac disorders | Arm B: AC followed by Eribulin | 0 | 6 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm A: Eribulin followed by AC | 1 | 16 | |
| other | Tinnitus | Ear and labyrinth disorders | Arm B: AC followed by Eribulin | 0 | 6 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm A: Eribulin followed by AC | 0 | 16 | |
| other | Hearing impaired | Ear and labyrinth disorders | Arm B: AC followed by Eribulin | 1 | 6 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A: Eribulin followed by AC | 1 | 16 |
| Total, all-cause mortality | Arm B: AC followed by Eribulin | 0 | 6 |
| Total, other adverse events | Arm A: Eribulin followed by AC | 16 | 16 |
| Total, other adverse events | Arm B: AC followed by Eribulin | 6 | 6 |
| Total, serious adverse events | Arm A: Eribulin followed by AC | 5 | 16 |
| Total, serious adverse events | Arm B: AC followed by Eribulin | 1 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41024110 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm A: Eribulin followed by AC vs Arm B: AC followed by Eribulin: deaths from any cause | Trial comparisons |
| Arm A: Eribulin followed by AC vs Arm B: AC followed by Eribulin: serious adverse events | 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/NCT02623972
GET https://conductscience.org/api/trials/v1/NCT02623972/events?page=2