Trial · NCT03112590

Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer

NCT03112590, Phase 1, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2022-06-08

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer. Trials, record NCT03112590. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03112590

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
NCT number: NCT03112590
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 51 participants, actual
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Conditions: Breast Cancer, Breast Cancer, Male, Breast Cancer Female, HER2-positive Breast Cancer
Interventions: Interferon-gamma (IFN-γ), Paclitaxel, Trastuzumab, Pertuzumab, Post Therapy Surgery
First posted: 2017-04-13
Last updated: 2023-04-19
Results first posted: 2022-06-08

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Phase 1: Recommended Phase 2 Dose (RP2D)	12 weeks	The dose limiting toxicity (DLT) evaluation period for dose escalation will be during the first three weeks. The maximum tolerated dose (MTD) dose level is defined as the highest dose level with ≤1 out of 6 participants experiencing a DLT. If the first dose level experience two or more DLTs, then dose de-escalation will occur. DLT during cycle one (C1) is defined as follows: Non-hematologic or hematologic toxicities that are ≥ grade 3 in severity and probably or definitely related to study therapy which leads to chemotherapy treatment delays \> 14 days are considered DLT. The MTD will become the RP2D.
Primary	Phase 2: Pathologic Complete Response Rate (pCR)	After post therapy surgery - Therapy: approximately 12 weeks per participant	Pathologic complete response in the breast at definitive surgery after completion of protocol therapy. The pathologic response to treatment will be assessed by an institutional pathologist at Moffitt Cancer Center. The pathologist will evaluate response by the "Residual Cancer Burden"(RCB) for each participant as described in the online calculator (see RCB link in the More Information section). pCR is defined as no residual invasive carcinoma in the breast and lymph notes at definitive surgery following neoadjuvant therapy
Secondary	Phase 2: Clinical Response	12 weeks	Complete Response (CR) and Partial Response (PR) based upon tumor measurements obtained on physical examination at baseline, after completion of 4 cycles of study therapy. Factors that will be evaluated include: Breast mass(es) - size (longest dimension); Axillary lymph node(s) - size (longest dimension); Skin edema of the breast - present worse, present unchanged, present improved, or absent; Skin erythema of the breast - present worse, present unchanged, present improved, or absent.
Secondary	Phase 2: Progression Free Survival (PFS)/Number of Participants Who Progressed	Up to 2 years	Progression will be evaluated in this study using the Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1. PFS is defined as the time from study therapy to the first occurrence of ipsilateral invasive breast tumor recurrence, ipsilateral locoregional invasive breast cancer recurrence, contralateral invasive breast cancer, distant recurrence, or death from any cause. This is reported as number of participants who progressed.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Phase 1: Recommended Phase 2 Dose (RP2D)	12 weeks		mcg/m^2	NUMBER
PRIMARY	Phase 2: Pathologic Complete Response Rate (pCR)	After post therapy surgery - Therapy: approximately 12 weeks per participant	Evaluable participants	percentage of participants	NUMBER
SECONDARY	Phase 2: Clinical Response	12 weeks	Evaluable participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Phase 2: Progression Free Survival (PFS)/Number of Participants Who Progressed	Up to 2 years	Evaluable participants	participants	NUMBER

Source ClinicalTrials.gov

Results by group7

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Phase 1: Recommended Phase 2 Dose (RP2D)	Combination Therapy		75	mcg/m^2
Phase 2: Pathologic Complete Response Rate (pCR)	Combination Therapy		52	percentage of participants
Phase 2: Clinical Response	Phase 2	Complete Response	25	Participants
Phase 2: Clinical Response	Phase 2	Partial Response	11	Participants
Phase 2: Clinical Response	Phase 2	Stable Disease	2	Participants
Phase 2: Clinical Response	Phase 2	Progressive Disease	1	Participants
Phase 2: Progression Free Survival (PFS)/Number of Participants Who Progressed	Phase 2		1	participants

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1 Level 1	3
Overall Study	STARTED	Phase 1 Level 2	6
Overall Study	STARTED	Phase 2	42
Overall Study	COMPLETED	Phase 1 Level 1	3
Overall Study	COMPLETED	Phase 1 Level 2	5
Overall Study	COMPLETED	Phase 2	42
Overall Study	NOT COMPLETED	Phase 1 Level 1	0
Overall Study	NOT COMPLETED	Phase 1 Level 2	1
Overall Study	NOT COMPLETED	Phase 2	0

Source ClinicalTrials.gov

Adverse events216

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	Abdominal Pain	Gastrointestinal disorders	Phase 1 Level 1	0	3	0
other	Abdominal Pain	Gastrointestinal disorders	Phase 1 Level 2	1	6	1
other	Abdominal Pain	Gastrointestinal disorders	Phase 2	0	42	0
other	Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	Phase 1 Level 1	0	3	0
other	Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	Phase 1 Level 2	1	6	1
other	Allergic Rhinitis	Respiratory, thoracic and mediastinal disorders	Phase 2	0	42	0
other	Alopecia	Skin and subcutaneous tissue disorders	Phase 1 Level 1	1	3	1
other	Alopecia	Skin and subcutaneous tissue disorders	Phase 1 Level 2	2	6	2
other	Alopecia	Skin and subcutaneous tissue disorders	Phase 2	2	42	2
other	Anemia	Blood and lymphatic system disorders	Phase 1 Level 1	1	3	1

1 to 10 of 216Source ClinicalTrials.gov

See all 216 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1 Level 1	0	3
Total, all-cause mortality	Phase 1 Level 2	0	6
Total, all-cause mortality	Phase 2	0	42
Total, other adverse events	Phase 1 Level 1	3	3
Total, other adverse events	Phase 1 Level 2	6	6
Total, other adverse events	Phase 2	4	42
Total, serious adverse events	Phase 1 Level 1	0	3
Total, serious adverse events	Phase 1 Level 2	2	6
Total, serious adverse events	Phase 2	2	42

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
35880940	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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