Neoplasms, Breast
Conditions
Keywords
Neoadjuvant Breast Cancer, Pazopanib (GW786034), NSABP Foundation, Inc., cyclophosphamide, Paclitaxel, Doxorubicin
Brief summary
The purpose of this study is to determine whether the treatment of a doxorubicin in combination with cyclophosphamide followed by a combination of pazopanib in combination with paclitaxel prior to surgery results in a pathological complete response in females with breast cancer.
Detailed description
This is a phase II non-randomized, multi-center study aimed to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel following treatment with cyclophosphamide and doxorubicin for the treatment of neoadjuvant breast cancer. Patients will receive standard doses of AC every 21 days for 4 cycles. This will be followed by weekly paclitaxel 80 mg/m2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with pazopanib 800 mg PO daily starting with the first paclitaxel dose and continuing until 7 days before surgery. Clinical complete response rate will be determined by tumor assessments performed by palpation at two time points: following AC (before paclitaxel/pazopanib begins) and 2-4 weeks following the last dose of paclitaxel (before surgery). Following recovery from preoperative therapy, patients will undergo the clinically-indicated surgery. Pazopanib will resume 4-6 weeks after surgery and continue daily for 6 months of postoperative pazopanib therapy.
Interventions
DRUGdoxorubicin + cyclophosphamide
4 cycles of doxorubicin + cyclophosphamide followed by 4 cycles of paclitaxel + pazopanib.
DRUGpaclitaxel + pazopanib
4 cycles of paclitaxel + pazopanib
PROCEDUREsurgery
neoadjuvant surgery for breast cancer
DRUGpazopanib monotherapy
6 months of treatment with pazopanib monotherapy
Sponsors
NSABP Foundation Inc
GlaxoSmithKline
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have consented to participate and must have signed and dated an appropriate IRB-approved consent form that conforms to federal and institutional guidelines for the study treatment and submission of tumor and blood samples required for the FB-6 correlative science studies * The ECOG performance status must be 0 or 1 * Patients must have the ability to swallow oral medication. * The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy. * Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. (Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors.) * Patients must have clinical stage IIIA, IIIB, or IIIC disease with a mass in the breast or axilla measuring at least 2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required. * Adequate organ function * LVEF assessment by 2-D echocardiogram or MUGA scan performed within 3 months prior to study entry must be greater or equal to 50% regardless of the facility's LLN. * ECG performed within 4 weeks before study entry must demonstrate a QTc interval that is less than or equal to 0.47 seconds. * The TSH level must be within normal limits for the laboratory.
Exclusion criteria
* Tumor that has been determined to be HER2-positive by immunohistochemistry (3+) or by FISH or CISH (positive for gene amplification), or has been determined to be HER2-equivocal and the investigator plans to administer trastuzumab or other targeted therapy. * FNA alone to diagnose the primary breast cancer. * Excisional biopsy or lumpectomy performed prior to study entry. * Surgical axillary staging procedure prior to study entry. * Definitive clinical or radiologic evidence of metastatic disease. * History of ipsilateral invasive breast cancer regardless of treatment or ipsilateral DCIS treated with RT. * Contralateral invasive breast cancer at any time. * Non-breast malignancies unless the patient is considered to be disease-free for 5 or more years prior to study entry and is deemed by her physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin. * Requirement for chronic use of any of the prohibited medications or substances * Previous therapy with anthracyclines, taxanes, or pazopanib for any malignancy. * Treatment including RT, chemotherapy, and/or targeted therapy, administered for the currently diagnosed breast cancer prior to study entry. * Continued therapy with any hormonal agent such as raloxifene, tamoxifen, or other SERM. * Any sex hormonal therapy, e.g., birth control pills and ovarian hormone replacement therapy * History of hepatitis B or C. * Symptomatic pancreatitis or asymptomatic greater or equal to grade 2 elevation of amylase or lipase as per NCI CTCAE v3.0. * History of documented pancreatitis. * Uncontrolled hypertension defined as systolic BP greater than 140 mmHg or diastolic BP greater greater than 90 mmHg, with or without anti-hypertensive medication. * History of hypertensive crisis or hypertensive encephalopathy. * Cardiac disease that would preclude the use of any of the drugs included in the FB-6 treatment regimen. * History of TIA or CVA. * History of any arterial thrombotic event within 12 months prior to study entry. * Pulmonary embolism or DVT within 6 months prior to study entry. * Symptomatic peripheral vascular disease. * Any significant bleeding within 6 months prior to study entry, exclusive of menorrhagia in premenopausal women. * Known bleeding diathesis, coagulopathy, or requirement for therapeutic doses of coumadin. * Serious or non-healing wound, skin ulcers, or bone fracture. * Gastroduodenal ulcer(s) determined by endoscopy to be active. * History of GI perforation, abdominal fistulae, or intra-abdominal abscess. * Malabsorption syndrome, ulcerative colitis, inflammatory bowel disease, resection of the stomach or small bowel, or other disease significantly affecting gastrointestinal function. * Sensory/motor neuropathy greater or equal to grade 2, as defined by the NCI's CTCAE v3.0. * Conditions that would prohibit intermittent administration of corticosteroids for paclitaxel premedication. * Anticipation of need for major surgical procedures (other than the required breast surgery) during the course of study therapy and for at least 3 months following the last dose of pazopanib. * Pregnancy or lactation at the time of study entry. * Other nonmalignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up. * Known immediate or delayed hypersensitivity reaction to doxorubicin, cyclophosphamide, paclitaxel, pazopanib, or drugs chemically related to pazopanib. * Use of any investigational agent within 4 weeks prior to enrollment in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes | From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry) | pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period | From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry | cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion. |
| Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods | From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry) | cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion. |
| Invasive Recurrence-free Interval (IRFI) | up to 24 months after study entry | IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer \[except LCIS\] in the ipsilateral breast \[IB\]/skin of the breast), regional (development of tumor in the ipsilateral \[IP\] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry. |
| Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period | From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry) | The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated. |
| Number of Participants With Pathologic Complete Response (pCR) in the Breast | From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry) | pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen. |
| Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period | From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry) | The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated. |
| Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | up to 24 months after study entry | The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges. |
| Number of Participants With the Indicated Radiotherapy-related Complications | up to 24 months after study entry | — |
| Number of Participants With Recurrence Events | up to 24 months after study entry | The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer \[except LCIS\] in the ipsilateral breast \[IB\]/skin of the breast), regional (development of tumor in the ipsilateral \[IP\] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry. |
| Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods | From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry). | The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared \[mg/m\^2\]) and cyclophosphamide (AC) (600 mg/m\^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m\^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months. | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Doxorubicin and Cyclophosphamide (AC) | Adverse Event | 1 |
| Doxorubicin and Cyclophosphamide (AC) | Disease Progression | 2 |
| Doxorubicin and Cyclophosphamide (AC) | Participant Moved | 1 |
| Doxorubicin and Cyclophosphamide (AC) | Physician Decision | 1 |
| Doxorubicin and Cyclophosphamide (AC) | Withdrawal by Subject | 1 |
| Pazopanib Postsurgery Treatment | Adverse Event | 19 |
| Pazopanib Postsurgery Treatment | Moved | 1 |
| Pazopanib Postsurgery Treatment | Site Thought Treatment Was Completed | 1 |
| Pazopanib Postsurgery Treatment | Withdrawal by Subject | 5 |
| Pazopanib Presurgery Treatment (PPT) | Adverse Event | 52 |
| Pazopanib Presurgery Treatment (PPT) | Never Started Pre-operative Pazopanib | 1 |
| Pazopanib Presurgery Treatment (PPT) | Physician Decision | 1 |
| Pazopanib Presurgery Treatment (PPT) | Withdrawal by Subject | 4 |
| Weekly Paclitaxel | Adverse Event | 11 |
| Weekly Paclitaxel | Disease Progression | 1 |
| Weekly Paclitaxel | Physician Decision | 3 |
| Weekly Paclitaxel | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib |
|---|---|
| Age, Continuous | 50.9 Years STANDARD_DEVIATION 9.72 |
| Number of participants with a positive or negative status for the indicated hormone receptors ER status negative | 28 participants |
| Number of participants with a positive or negative status for the indicated hormone receptors Estrogen receptor (ER) status positive | 73 participants |
| Number of participants with a positive or negative status for the indicated hormone receptors HER-2/NEU status equivocal (uncertain) | 1 participants |
| Number of participants with a positive or negative status for the indicated hormone receptors HER-2/NEU status negative | 99 participants |
| Number of participants with a positive or negative status for the indicated hormone receptors HER-2/NEU status positive | 1 participants |
| Number of participants with a positive or negative status for the indicated hormone receptors PgR status negative | 39 participants |
| Number of participants with a positive or negative status for the indicated hormone receptors Progesterone receptor (PgR) status positive | 62 participants |
| Number of participants with the indicted hormonal status (ER+ and PR+ / ER- and PR-) Negative | 27 participants |
| Number of participants with the indicted hormonal status (ER+ and PR+ / ER- and PR-) Positive | 74 participants |
| Race/Ethnicity, Customized African American/African Heritage | 10 participants |
| Race/Ethnicity, Customized AI or AN + White - W/C/EH | 1 participants |
| Race/Ethnicity, Customized American Indian (AI) or Alaskan Native (AN) | 1 participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 1 participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 1 participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 3 participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 3 participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage (W/C/EH) | 81 participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 101 / 101 |
| serious Total, serious adverse events | 15 / 101 |
Outcome results
Primary
Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen, axillary nodes, or sentinel node identified after neoadjuvant chemotherapy.
Time frame: From the start of the study until the time of surgery (average of 221.9 days [standard deviation of 23.65 days] after study entry)
Population: Evaluable Population: all participants who entered the study and received at least one dose of pazopanib.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes | 16 Participants |
95% CI: [10.64, 27.55]
Secondary
Invasive Recurrence-free Interval (IRFI)
IRFI was assessed as the time from study entry until the diagnosis of the first invasive local (evidence of invasive/in situ breast cancer \[except LCIS\] in the ipsilateral breast \[IB\]/skin of the breast), regional (development of tumor in the ipsilateral \[IP\] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.
Time frame: up to 24 months after study entry
Population: Evaulable Population. Participants with recurrence before study entry were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Invasive Recurrence-free Interval (IRFI) | NA months |
Secondary
Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.
Time frame: From the start of the study until the preoperative evaluation (an average of 86.2 days [standard deviation of 5.76 days] after study entry)
Population: Treated Population: all participants who entered the study and received at least one dose of any study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Cardiac Toxicity (Per Common Terminology Criteria for Adverse Events Version 3) at the Completion of the AC Period | 0 Participants |
Secondary
Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.
Time frame: From the start of the study until the end of the postoperative pazopanib period, which coincides with the start of the end of treatment period (an average of 310.8 days [standard deviation of 85.29 days] after study entry)
Population: Treated Population: Only those members of the Treated Population who started the postoperative pazopanib period were assessed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Cardiac Toxicity (Per CTCAE Version 3.0) During the Postoperative Pazopanib Period | 0 Participants |
Secondary
Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods
The number of participants with cardiac toxicity was defined as those who had cardiac events of Grades (G) 3 and 4 leftventricular dysfunction (LVD) (CTCAE Version 3.0) and/or who had definite or probable cardiac death. Grade refers to the severity of the AE: G 1, mild AE; G 2, moderate AE; G 3, severe AE; G 4, life-threatening/disabling AE; G 5, death related to the AE. A G3 LVD event is defined as symptomatic congestive heart failure (CHF) responsive to intervention. A G4 event is defined as poorly controlled refractory CHF; ventricular assist device or heart transplant indicated.
Time frame: From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry).
Population: Treated Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Cardiac Toxicity (Per CTCAE Version 3) at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods | 0 Participants |
Secondary
Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period
cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.
Time frame: From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry
Population: Evaluable Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Clinical Complete Response (cCR) in the Breast and Nodes at the Completion of the Doxorubicin and Cyclophosphamide (AC) Period | 22 Participants |
Secondary
Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods
cCR was determined by tumor assessments performed by palpation. All clinical response assessments were to be performed by physical examination of the breast and the axilla. cCR was defined as the resolution of all target and non-target lesions identified at Baseline and no new lesions or other signs of disease progression. The criteria to be used for the determination of progressive disease were at the investigator's discretion.
Time frame: From the start of the study until the preoperative evaluation (an average of 203.0 days [standard deviation of 23.19 days] after study entry)
Population: Evaluable Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Clinical CR (cCR) in the Breast and Nodes at the Completion of the AC and Weekly Paclitaxel (WP) + Pazopanib Preoperative Periods | 39 Participants |
Secondary
Number of Participants With Pathologic Complete Response (pCR) in the Breast
pCR was defined as no histologic evidence of invasive tumor cells in the surgical breast specimen.
Time frame: From the start of the study until the time of surgery (average of 221.9 [standard deviation of 23.65 days] days after study entry)
Population: Evaluable Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Pathologic Complete Response (pCR) in the Breast | 18 Participants |
Secondary
Number of Participants With Recurrence Events
The number of participants with recurrence events during the 24 months after study entry are reported. A recurrence event is defined as invasive local (evidence of invasive/in situ breast cancer \[except LCIS\] in the ipsilateral breast \[IB\]/skin of the breast), regional (development of tumor in the ipsilateral \[IP\] internal mammary, IP supraclavicular, IP infraclavicular, and/or IP axillary nodes, as well as the soft tissue of the IP axilla, following surgery), or distant (evidence of tumor in all areas, with the exception of those described for local and regional recurrence) breast cancer recurrence during the 24 months after study entry.
Time frame: up to 24 months after study entry
Population: Evaulable Population, excluding participants with recurrence before study entry
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With Recurrence Events | 15 participants |
Secondary
Number of Participants With the Indicated Radiotherapy-related Complications
Time frame: up to 24 months after study entry
Population: Treated Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With the Indicated Radiotherapy-related Complications | Rash | 57 participants |
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Number of Participants With the Indicated Radiotherapy-related Complications | Pneumonitis | 1 participants |
Secondary
Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods
The number of participants with normal thyroid function at Baseline who had an elevation in TSH during the study were recorded. TSH elevation was derived based on local laboratory ranges.
Time frame: up to 24 months after study entry
Population: Treated Population. Data are presented for only those participants who remained in the study during the indicated period and had their blood drawn for assessment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | Elevated TSH at Least Once during the Study, n=101 | 28 participants |
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | AC Period, n=91 | 2 participants |
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | (WP) + Pazopanib Preoperative Periods, n=89 | 15 participants |
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | Surgery Period, n=78 | 1 participants |
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | Postoperative Pazopanib Period, n=36 | 7 participants |
| AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib | Participants With Normal Thyroid Stimulating Hormone (TSH) Levels at Baseline Who Had an Elevated TSH Level at Least Once During the Study and During the Individual Study Periods | Follow-up Period, n=33 | 8 participants |