A Phase 2 interventional study of sunitinib malate and paclitaxel in Inflammatory Breast Cancer, Male Breast Cancer and Stage II Breast Cancer, sponsored by University of Washington. Completed at 7 sites in United States. Per ClinicalTrials.gov, last updated 2019-08-07.
Sponsored by University of Washington · Phase 2, Interventional, and Treatment
This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PRIMARY OBJECTIVES:
I.To assess the microscopic pathologic complete response rate (pCR) in patients treated with a two part, neoadjuvant regimen consisting of daily oral sunitinib with weekly IV paclitaxel for 12 weeks followed by weekly doxorubicin and daily oral cyclophosphamide given with filgrastim (G-CSF) support for 15 weeks.
SECONDARY OBJECTIVES:
I. To assess the association between microscopic pCR and clinical complete response rate at the primary tumor site.
II. To assess the relapse rate, overall and disease-free survival in patients with breast cancer treated with neoadjuvant chemotherapy consisting of daily oral sunitinib with weekly IV paclitaxel for 12 weeks followed weekly doxorubicin and daily oral cyclophosphamide given with G-CSF support for 15 weeks.
III. To assess the toxicity associated with these regimens. IV. To explore the relationship between planned correlative laboratory and clinical studies and indicators of efficacy such as pathologic response, clinical response and relapse.
OUTLINE:
Patients receive neoadjuvant chemotherapy comprising sunitinib malate orally (PO) once daily and paclitaxel intravenously (IV) over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim subcutaneously (SC) on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 68 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive neoadjuvant chemotherapy comprising sunitinib malate PO once daily and paclitaxel IV over 1 hour once weekly for 8-12 weeks in the absence of disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks, cyclophosphamide PO once daily for 15 weeks, and filgrastim SC on days 2-7 for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6 weeks after completion of chemotherapy, patients undergo surgery.
Drug: sunitinib malate · Drug: paclitaxel · Drug: doxorubicin hydrochloride · Drug: cyclophosphamide · Biological: filgrastim · Procedure: therapeutic conventional surgery · Other: laboratory biomarker analysis · Other: flow cytometry
Given PO
Also known as: SU11248, sunitinib, Sutent
Given IV
Also known as: Anzatax, Asotax, TAX, Taxol
Given IV
Also known as: ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF
Given PO
Also known as: CPM, CTX, Cytoxan, Endoxan, Endoxana
Given SC
Also known as: G-CSF, Neupogen
Undergo surgery
Correlative studies
Correlative studies
Microscopic Pathologic CR (pCR) Rate
Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.
Time frame: At the time of surgery
Clinical Complete Response and Correlation With Plasma VEGF, Soluble VCAM (sVCAM), and Circulating Endothelial Cells (CECs) Levels
Time frame: At baseline, after week 12 of therapy, and prior to surgery
Relapse Rate
Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.
Time frame: Up to two years
Time to Disease Progression
Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.
Time frame: Up to 2 years
Overall Survival
Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years.
Time frame: Up to 2 years
Number and Percent of Subjects Reporting Adverse Events
See Adverse Events section for more details.
Time frame: 28 days after the last dose of study drug
| Milestone | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Started | 68 |
| Completed | 63 |
| Not completed | 5 |
| Withdrew: Discontinued therapy | 2 |
| Withdrew: Progression prior to surgery | 3 |
Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.
| percent of evaluable participants | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Microscopic Pathologic CR (pCR) Rate | 27 (18 to 39) |
No measurements were reported for this outcome.
Cumulative incidence rate of relapse, assessed at two years. Death is considered a competing risk.
| probability of relapse | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Relapse Rate | 0.215 (0.125 to 0.322) |
Median time to disease progression, at two years, as defined by clear increase in disease sites present at registration or development of new disease sites.
| days | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Time to Disease Progression | NA (NA to NA) |
Kaplan-Meier estimate from the start of protocol therapy until the date of death from any cause or the last date the patient was known to be alive, assessed at two years.
| survival probability | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Overall Survival | 0.875 (0.798 to 0.960) |
See Adverse Events section for more details.
| Participants | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Number and Percent of Subjects Reporting Adverse Events | 67 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (Neoadjuvant Chemotherapy Before Surgery) | — | 47/68 (69.1%) | 67/68 (98.5%) |
| Event | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Neutropenia (ANC)Blood and lymphatic system disorders | 47/68 |
| LeucopeniaBlood and lymphatic system disorders | 23/68 |
| AnemiaBlood and lymphatic system disorders | 15/68 |
| MucositisRespiratory, thoracic and mediastinal disorders | 7/68 |
| ALT elevationInvestigations | 4/68 |
| FatigueGeneral disorders | 3/68 |
| DiarrheaGastrointestinal disorders | 3/68 |
| Sensory NeuropathyNervous system disorders | 3/68 |
| PainGeneral disorders | 2/68 |
| Nail changesSkin and subcutaneous tissue disorders | 2/68 |
| Event | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| FatigueGeneral disorders | 37/68 |
| LeucopeniaBlood and lymphatic system disorders | 34/68 |
| AnemiaBlood and lymphatic system disorders | 32/68 |
| Neutropenia (ANC)Blood and lymphatic system disorders | 22/68 |
| PainGeneral disorders | 15/68 |
| Nail changesSkin and subcutaneous tissue disorders | 12/68 |
| DiarrheaGastrointestinal disorders | 9/68 |
| RashSkin and subcutaneous tissue disorders | 8/68 |
| HypertensionVascular disorders | 8/68 |
| HeartburnGastrointestinal disorders | 8/68 |
| Age, Continuous(years) | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Median | 50 (33 to 79) |
| Sex: Female, Male(Participants) | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Female | 68 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 56 |
| Unknown or Not Reported | 8 |
| Race (NIH/OMB)(Participants) | Treatment (Neoadjuvant Chemotherapy Before Surgery) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 50 |
| More than one race | 4 |
| Unknown or Not Reported | 8 |
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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