Trials / Completed
CompletedNCT03112590
Phase I-II Study of Interferon-gamma in Patients With HER-2 Positive Breast Cancer
A Phase I-II Study of Interferon-gamma Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This purpose of this study is to evaluate the safety and to find the optimal dose in participants with human epidermal growth factor receptor 2 (HER2) positive breast cancer who are given the combination of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab. This study will also look at other effects of Interferon-gamma with paclitaxel, trastuzumab and pertuzumab, including its effect on this type of cancer. Interferon-gamma is a biologically manufactured protein that is similar to a protein the body makes naturally. In the body, interferon gamma is produced by immune cells and helps to prevent serious infections.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Interferon-gamma (IFN-γ) | Phase 1: IFN-γ 50 or 75 mcg/m\^2 SQ x 3 days/week for 12 weeks. Phase 2: IFN-γ at Recommended Phase II Dose (RP2D) subcutaneously (SQ) x 3 days/week, for 12 weeks. |
| DRUG | Paclitaxel | Phase 1 and Phase 2: Paclitaxel 80 mg/m\^2/week, for 12 weeks. |
| DRUG | Trastuzumab | Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks. |
| OTHER | Pertuzumab | Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks. |
| PROCEDURE | Post Therapy Surgery | Phase 2: Participants will be assessed for surgery following the fourth cycle of study therapy (or earlier if study treatment is cancelled due to unmanageable side effects). |
Timeline
- Start date
- 2017-06-23
- Primary completion
- 2021-03-31
- Completion
- 2023-02-20
- First posted
- 2017-04-13
- Last updated
- 2023-04-19
- Results posted
- 2022-06-08
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03112590. Inclusion in this directory is not an endorsement.