A Phase 1/2 interventional study of Interferon-gamma (IFN-γ) and Paclitaxel in Breast Cancer, Breast Cancer, Male and Breast Cancer Female, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-19.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 1/2, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 51 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Exclusion Criteria:
Phase 1: Participants with HER-2 positive metastatic breast cancer enrolled in groups of 3-6 or more; each group participant to be given the same dose and schedule of Interferon-gamma plus paclitaxel, trastuzumab, and pertuzumab. If group participants do not have bad side effects, the next group will be given a higher dose of Interferon-gamma. This will continue until the highest safe dose of Interferon-gamma is found. Once highest safe dose of Interferon-gamma is found, participants may be enrolled in Phase II. Phase 2: Approximately 31 participants with Stage 2-3 HER2 positive early stage breast cancer enrolled to receive therapy with Interferon-gamma plus paclitaxel, trastuzumab, and pertuzumab. Interferon-gamma given at dose found in the Phase 1. Phase 2: Post therapy surgery.
Biological: Interferon-gamma (IFN-γ) · Drug: Paclitaxel · Drug: Trastuzumab · Other: Pertuzumab · Procedure: Post Therapy Surgery
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.
Also known as: Actimmune®, signaling proteins
Phase 1 and Phase 2: Paclitaxel 80 mg/m\^2/week, for 12 weeks.
Also known as: Abraxane®
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.
Also known as: Herceptin®
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.
Also known as: PERJETA®, monoclonal antibody
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).
Phase 1: Recommended Phase 2 Dose (RP2D)
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.
Time frame: 12 weeks
Phase 2: Pathologic Complete Response Rate (pCR)
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
Time frame: After post therapy surgery - Therapy: approximately 12 weeks per participant
Phase 2: Clinical Response
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.
Time frame: 12 weeks
Phase 2: Progression Free Survival (PFS)/Number of Participants Who Progressed
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.
Time frame: Up to 2 years
| Milestone | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 |
|---|---|---|---|
| Started | 3 | 6 | 42 |
| Completed | 3 | 5 | 42 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Adverse event | 0 | 1 | 0 |
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.
| mcg/m^2 | Combination Therapy |
|---|---|
| Phase 1: Recommended Phase 2 Dose (RP2D) | 75 |
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
| percentage of participants | Combination Therapy |
|---|---|
| Phase 2: Pathologic Complete Response Rate (pCR) | 52 |
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.
| Participants | Phase 2 |
|---|---|
| Complete Response | 25 |
| Partial Response | 11 |
| Stable Disease | 2 |
| Progressive Disease | 1 |
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.
| participants | Phase 2 |
|---|---|
| Phase 2: Progression Free Survival (PFS)/Number of Participants Who Progressed | 1 |
Collected over Adverse events were collected from date of on study to 30 days after last dose of study treatment, up to 4 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase 1 Level 1 | 0/3 (0%) | 0/3 (0%) | 3/3 (100%) |
| Phase 1 Level 2 | 0/6 (0%) | 2/6 (33.3%) | 6/6 (100%) |
| Phase 2 | 0/42 (0%) | 2/42 (4.8%) | 4/42 (9.5%) |
| Event | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 |
|---|---|---|---|
| Sinus tachycardiaCardiac disorders | 0/3 | 1/6 | 1/42 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/3 | 1/6 | 1/42 |
| DiarrheaGastrointestinal disorders | 0/3 | 1/6 | 0/42 |
| Respiratory, thoracic and mediastinal disorders - OtherRespiratory, thoracic and mediastinal disorders | 0/3 | 1/6 | 0/42 |
| WheezingRespiratory, thoracic and mediastinal disorders | 0/3 | 1/6 | 0/42 |
| FeverGeneral disorders | 0/3 | 1/6 | 0/42 |
| Abdominal painGastrointestinal disorders | 0/3 | 1/6 | 0/42 |
| Laryngeal inflammationRespiratory, thoracic and mediastinal disorders | 0/3 | 1/6 | 0/42 |
| HypertensionVascular disorders | 0/3 | 0/6 | 1/42 |
| GastritisGastrointestinal disorders | 0/3 | 0/6 | 1/42 |
| Event | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 |
|---|---|---|---|
| DiarrheaGastrointestinal disorders | 3/3 | 1/6 | 1/42 |
| FatigueGeneral disorders | 3/3 | 2/6 | 1/42 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 3/3 | 3/6 | 2/42 |
| ConstipationGastrointestinal disorders | 2/3 | 1/6 | 0/42 |
| MyalgiaMusculoskeletal and connective tissue disorders | 2/3 | 2/6 | 0/42 |
| NauseaGastrointestinal disorders | 2/3 | 0/6 | 4/42 |
| Skin and subcutaneous tissue disorders - OtherSkin and subcutaneous tissue disorders | 2/3 | 0/6 | 0/42 |
| FeverGeneral disorders | 1/3 | 3/6 | 0/42 |
| Infusion related reactionGeneral disorders | 0/3 | 3/6 | 2/42 |
| Peripheral sensory neuropathyNervous system disorders | 0/3 | 3/6 | 0/42 |
| Age, Categorical(Participants) | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 3 | 6 | 28 | 37 |
| >=65 years | 0 | 0 | 14 | 14 |
| Sex: Female, Male(Participants) | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 | Total |
|---|---|---|---|---|
| Female | 3 | 6 | 42 | 51 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 5 | 5 |
| Not Hispanic or Latino | 3 | 6 | 37 | 46 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 0 | 1 |
| White | 3 | 3 | 37 | 43 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 3 | 3 |
| Region of Enrollment(participants) | Phase 1 Level 1 | Phase 1 Level 2 | Phase 2 | Total |
|---|---|---|---|---|
| United States | 3 | 6 | 42 | 51 |
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H. Lee Moffitt Cancer Center and Research Institute