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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | The study will be conducted in 3 sequential treatment segments. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sunitinib alone | Drug | sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy | Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value. | baseline through end of segment 1 (2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy | Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Miller, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | 46202 | United States |
Please note that one patient discontinued due to an Adverse Event after completing Segment 2 (Paclitaxel/Sunitinib), but before starting Segment 3 adriamycin & cyclophosphamide (AC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Segment Information | This is an exploratory phase 2 and biomarker clinical trial of sunitinib in the neoadjuvant setting for the treatment of breast cancer. The study will be conducted in 3 sequential treatment segments. During the first segment, patients will receive single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. Patients will then begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. Sunitinib will be discontinued after Cycle 5 Day 21. The third segment will include 4 cycles (8 weeks) of neoadjuvant treatment with AC followed by surgical resection and determination of pathological response. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Single Agent Sunitinib (Cycle 1) |
| |||||||||||||
| Paclitaxel/Sunitinib (Cycles 2-5) |
| |||||||||||||
| AC (Cycles 6-9) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | These patients are for the patients who were into the trial. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy | Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value. | All patients that had both measures at baseline and endpoint in the sunitinib monotherapy segment | Posted | Mean | Standard Deviation | mm Hg | baseline through end of segment 1 (2 weeks) |
|
|
Cycles 1 through 9 of treatment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Agent Sunitinib | Single-agent sunitinib for 2 weeks for the purpose of biomarker and IFP evaluation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| DERMAL CHANGE LYMPHEDEMA, PHLEBOLYMPHEDEMA | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kathy Miller | IndianaU | 317-944-0920 |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077210 | Sunitinib |
| D017239 | Paclitaxel |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| sunitinib plus paclitaxel | Drug | sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. |
|
| doxorubicin and cyclophosphamide | Drug | doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC. |
|
| end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days) |
| Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer | screening through surgery |
| To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy | This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib. | end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) |
|
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
|
| Secondary | Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy | Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value. | All patients in the paclitaxel plus sunitinib segment | Posted | Mean | Standard Deviation | mm Hg | end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days) |
|
|
|
|
| Secondary | Pathological Complete Response (pCR) Rate for Patients Treated With Sunitinib/Paclitaxel Followed by AC as Neoadjuvant Therapy for Breast Cancer | All patients who had surgery. | Posted | Number | 95% Confidence Interval | percentage of participants | screening through surgery |
|
|
|
| Secondary | To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy | This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib. | All patients who were on paclitaxel plus sunitinib. | Posted | Number | participants | end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) |
|
|
|
| 0 |
| 23 |
| 20 |
| 23 |
| EG001 | Paclitaxel/Sunitinib | 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel. | 2 | 23 | 22 | 23 |
| EG002 | AC Dosing | 4 cycles (8 weeks) of neoadjuvant treatment with AC. | 2 | 16 | 16 | 16 |
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
|
| BILIRUBIN (HYPERBILIRUBINEMIA) | Hepatobiliary disorders | Non-systematic Assessment |
|
| INFECTION (DOCUMENTED CLINICALLY OR MICROBIOLOGICALLY) WITH GRADE 3 OR 4 NEUTROPHILS (ANC <1.0 X 10E | Infections and infestations | Non-systematic Assessment |
|
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | Investigations | Non-systematic Assessment |
|
| FEBRILE NEUTROPENIA (FEVER OF UNKNOWN ORIGIN WITHOUT CLINICALLY OR MICROBIOLOGICALLY DOCUMENTED INFE | Investigations | Non-systematic Assessment |
|
| LEFT VENTRICULAR SYSTOLIC DYSFUNCTION | Cardiac disorders | Non-systematic Assessment |
|
| VENTRICULAR ARRHYTHMIA - VENTRICULAR TACHYCARDIA | Cardiac disorders | Non-systematic Assessment |
|
| DRY EYE SYNDROME | Eye disorders | Non-systematic Assessment |
|
| OCULAR/VISUAL - OTHER (SPECIFY, __) | Eye disorders | Non-systematic Assessment |
|
| VISION-BLURRED VISION | Eye disorders | Non-systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | Non-systematic Assessment |
|
| DIARRHEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| HEARTBURN/DYSPEPSIA | Gastrointestinal disorders | Non-systematic Assessment |
|
| HEMORRHOIDS | Gastrointestinal disorders | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (CLINICAL EXAM) - ORAL CAVITY | Gastrointestinal disorders | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - ORAL CAVITY | Gastrointestinal disorders | Non-systematic Assessment |
|
| MUCOSITIS/STOMATITIS (FUNCTIONAL/SYMPTOMATIC) - STOMACH | Gastrointestinal disorders | Non-systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | Non-systematic Assessment |
|
| TASTE ALTERATION (DYSGEUSIA) | Gastrointestinal disorders | Non-systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | Non-systematic Assessment |
|
| FATIGUE (ASTHENIA, LETHARGY, MALAISE) | General disorders | Non-systematic Assessment |
|
| FEVER (IN THE ABSENCE OF NEUTROPENIA, WHERE NEUTROPENIA IS DEFINED AS ANC <1.0 X 10E9/L) | General disorders | Non-systematic Assessment |
|
| PAIN - ABDOMEN NOS | General disorders | Non-systematic Assessment |
|
| PAIN - BACK | General disorders | Non-systematic Assessment |
|
| PAIN - BREAST | General disorders | Non-systematic Assessment |
|
| PAIN - CARDIAC/HEART | General disorders | Non-systematic Assessment |
|
| PAIN - CHEST/THORAX NOS | General disorders | Non-systematic Assessment |
|
| PAIN - EXTREMITY-LIMB | General disorders | Non-systematic Assessment |
|
| PAIN - HEAD/HEADACHE | General disorders | Non-systematic Assessment |
|
| PAIN - JOINT | General disorders | Non-systematic Assessment |
|
| PAIN - MUSCLE | General disorders | Non-systematic Assessment |
|
| PAIN - OTHER (SPECIFY, __) | General disorders | Non-systematic Assessment |
|
| PAIN - STOMACH | General disorders | Non-systematic Assessment |
|
| PAIN - THROAT/PHARYNX/LARYNX | General disorders | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - PARANASAL | Infections and infestations | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SINUS | Infections and infestations | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - SKIN (CELLULITIS) | Infections and infestations | Non-systematic Assessment |
|
| INFECTION WITH NORMAL ANC OR GRADE 1 OR 2 NEUTROPHILS - UPPER AIRWAY NOS | Infections and infestations | Non-systematic Assessment |
|
| INFECTION WITH UNKNOWN ANC - URINARY TRACT NOS | Infections and infestations | Non-systematic Assessment |
|
| BURN | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| ALT, SGPT (SERUM GLUTAMIC PYRUVIC TRANSAMINASE) | Investigations | Non-systematic Assessment |
|
| AST, SGOT(SERUM GLUTAMIC OXALOACETIC TRANSAMINASE) | Investigations | Non-systematic Assessment |
|
| HEMOGLOBIN | Investigations | Non-systematic Assessment |
|
| NEUTROPHILS/GRANULOCYTES (ANC/AGC) | Investigations | Non-systematic Assessment |
|
| PLATELETS | Investigations | Non-systematic Assessment |
|
| ANOREXIA | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| NEUROPATHY: SENSORY | Nervous system disorders | Non-systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | Non-systematic Assessment |
|
| MOOD ALTERATION - ANXIETY | Psychiatric disorders | Non-systematic Assessment |
|
| MOOD ALTERATION - DEPRESSION | Psychiatric disorders | Non-systematic Assessment |
|
| HOT FLASHES/FLUSHES | Reproductive system and breast disorders | Non-systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| DYSPNEA (SHORTNESS OF BREATH) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| HEMORRHAGE, PULMONARY/UPPER RESPIRATORY - NOSE | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| PULMONARY/UPPER RESPIRATORY - OTHER (SPECIFY, __) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| HAIR LOSS/ALOPECIA (SCALP OR BODY) | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| HYPERPIGMENTATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| HYPOPIGMENTATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| NAIL CHANGES | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| PRURITUS/ITCHING | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| RASH/DESQUAMATION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| RASH: ACNE/ACNEIFORM | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| RASH: HAND-FOOT SKIN REACTION | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| HYPERTENSION | Vascular disorders | Non-systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |
| D007211 |
| Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |