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Neoplasms, BreastPhase 2NCT00849472

Treatment With Pazopanib for Neoadjuvant Breast Cancer

A Phase 2 study testing doxorubicin + cyclophosphamide, paclitaxel + pazopanib and surgery in people with Neoplasms, Breast, run by GlaxoSmithKline at 143 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Neoplasms, Breast
What is being tested?
doxorubicin + cyclophosphamide, paclitaxel + pazopanib and surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
143 sitesin 2 countries
Study dates
Jul 2009to Apr 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 36Show fewer
  • 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.

Trial locations and contacts

143 sites in 2 countries.

143 sites in 2 countries

United States137 sites

  • GSK Investigational Site

    Ann Arbor, Michigan, 48106

  • GSK Investigational Site

    Antioch, California, 94531

  • GSK Investigational Site

    Baltimore, Maryland, 21237

  • GSK Investigational Site

    Battle Creek, Michigan, 49016

  • GSK Investigational Site

    Brighton, Michigan, 48114

  • GSK Investigational Site

    Brunsville, Minnesota, 55337

  • GSK Investigational Site

    Byron Center, Michigan, 49519

  • GSK Investigational Site

    Canton, Ohio, 44710

  • GSK Investigational Site

    Chargrin, Ohio, 44122

  • GSK Investigational Site

    Charlotte, North Carolina, 28203

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Charlotte, North Carolina, 28210

  • GSK Investigational Site

    Charlotte, North Carolina, 28211

  • GSK Investigational Site

    Charlotte, North Carolina, 28262

  • GSK Investigational Site

    Chippewa Falls, Wisconsin, 54729

  • GSK Investigational Site

    Clevand, Ohio, 44106

  • GSK Investigational Site

    Clinton, North Carolina, 28328

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Dayton, Ohio, 45331

  • GSK Investigational Site

    Dayton, Ohio, 45415

  • GSK Investigational Site

    Dayton, Ohio, 45429

  • GSK Investigational Site

    Dearborn, Michigan, 48123

  • GSK Investigational Site

    Dearborn, Michigan, 48162

  • GSK Investigational Site

    Decatur, Alabama, 35601

  • GSK Investigational Site

    Denver, Colorado, 80205

  • GSK Investigational Site

    Denver, Colorado, 80210

  • GSK Investigational Site

    Denver, Colorado, 80218

  • GSK Investigational Site

    Denver, Colorado, 80224

  • GSK Investigational Site

    Denver, Colorado, 80244

  • GSK Investigational Site

    Detroit, Michigan, 48236

  • GSK Investigational Site

    Eau Claire, Wisconsin, 54701

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Englewood, Colorado, 80113

  • GSK Investigational Site

    Ephrata, Pennsylvania, 17522

  • GSK Investigational Site

    Fernandina Beach, Florida, 32034

  • GSK Investigational Site

    Flint, Michigan, 48502

  • GSK Investigational Site

    Flint, Michigan, 48503

  • GSK Investigational Site

    Flint, Michigan, 48532

  • GSK Investigational Site

    Fremont, California, 94538

  • GSK Investigational Site

    Fridley, Minnesota, 55432

  • GSK Investigational Site

    Gainesville, Florida, 32610

  • GSK Investigational Site

    Goldsboro, North Carolina, 27534

  • GSK Investigational Site

    Grand Rapids, Michigan, 49503

  • GSK Investigational Site

    Greeley, Colorado, 80631

  • GSK Investigational Site

    Greensburg, Pennsylvania, 15601

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Grosse Point Woods, Michigan, 19229

  • GSK Investigational Site

    Hayward, California, 94545

  • GSK Investigational Site

    Honolulu, Hawaii, 96819

  • GSK Investigational Site

    Huntsville, Alabama, 35801

  • GSK Investigational Site

    Huntsville, Alabama, 35805

  • GSK Investigational Site

    Iowa City, Iowa, 52242

  • GSK Investigational Site

    Jacksonville, Florida, 32205

  • GSK Investigational Site

    Jacksonville, Florida, 32207

  • GSK Investigational Site

    Jacksonville, Florida, 32256

  • GSK Investigational Site

    Jacksonville, Florida, 32258

  • GSK Investigational Site

    Jeffersonville, Kentucky, 47130

  • GSK Investigational Site

    Kettering, Ohio, 45409

  • GSK Investigational Site

    Kettering, Ohio, 45429

  • GSK Investigational Site

    Lafayette, Colorado, 80026

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Lansing, Michigan, 48912

  • GSK Investigational Site

    Lebanon, Ohio, 45036

  • GSK Investigational Site

    Livonia, Michigan, 48154

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Louisville, Kentucky, 40207

  • GSK Investigational Site

    Louisville, Kentucky, 40217

  • GSK Investigational Site

    Louisville, Kentucky

  • GSK Investigational Site

    Lubbock, Texas, 79410

  • GSK Investigational Site

    Maplewood, Minnesota, 55109

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Mentor, Ohio, 44060

  • GSK Investigational Site

    Middletown, Ohio, 45042

  • GSK Investigational Site

    Minneapolis, Minnesota, 55433

  • GSK Investigational Site

    Minneapolis, Minnesota, 55454

  • GSK Investigational Site

    Minocqua, Wisconsin, 54548

  • GSK Investigational Site

    Mount Clemens, Michigan, 48043

  • GSK Investigational Site

    Muskegon, Michigan, 49444

  • GSK Investigational Site

    New Brunswick, New Jersey, 08901

  • GSK Investigational Site

    Oakland, California, 94611

  • GSK Investigational Site

    Orange Park, Florida, 32073

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19107

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19115

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19141

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15215

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15237

  • GSK Investigational Site

    Port Huron, Michigan, 48060

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    Portland, Oregon, 97225

  • GSK Investigational Site

    Portland, Oregon

  • GSK Investigational Site

    Redwood City, California, 94063

  • GSK Investigational Site

    Rhinelander, Wisconsin, 54501

  • GSK Investigational Site

    Rice Lake, Wisconsin, 54868

  • GSK Investigational Site

    Richmond, California, 94801

  • GSK Investigational Site

    Richmond, Virginia, 23235

  • GSK Investigational Site

    Richmond, Virginia, 23298

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Sacramento, California, 95823

  • GSK Investigational Site

    Sacramento, California, 95825

  • GSK Investigational Site

    Saginaw, Michigan, 48601

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55416

  • GSK Investigational Site

    Saint Paul, Minnesota, 55101

  • GSK Investigational Site

    Saint Paul, Minnesota, 55102

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    San Jose, California, 95119-1110

  • GSK Investigational Site

    San Rafael, California, 94903

  • GSK Investigational Site

    Santa Clara, California, 95051

  • GSK Investigational Site

    Santa Rosa, California, 95403-2192

  • GSK Investigational Site

    Savannah, Georgia, 31404

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Seattle, Washington, 98101

  • GSK Investigational Site

    South San Francisco, California, 94080

  • GSK Investigational Site

    Stevens Point, Wisconsin, 54481

  • GSK Investigational Site

    Stockton, California, 95210

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Traverse City, Michigan, 49684

  • GSK Investigational Site

    Vacaville, California, 95688

  • GSK Investigational Site

    Vallejo, California, 94589

  • GSK Investigational Site

    Vancouver, Washington, 98668

  • GSK Investigational Site

    Vancover, Washington, 98684

  • GSK Investigational Site

    Walnut Creek, California, 94596

  • GSK Investigational Site

    Warren, Michigan, 48093

  • GSK Investigational Site

    West Reading, Pennsylvania, 19611

  • GSK Investigational Site

    Westlake, Ohio, 44145

  • GSK Investigational Site

    Weston, Wisconsin, 54476

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80033

  • GSK Investigational Site

    Wheat Ridge, Colorado, 80333

  • GSK Investigational Site

    Wilminton, Ohio, 45042

  • GSK Investigational Site

    Wilson, North Carolina, 27893

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27014

  • GSK Investigational Site

    Winston-Salem, North Carolina, 27157

  • GSK Investigational Site

    Wisconsin Rapids, Wisconsin, 54494

  • GSK Investigational Site

    Woodbury, Minnesota, 55125

  • GSK Investigational Site

    Xenia, Ohio, 45385

Other trials in United States

Canada6 sites

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H3A 1A1

  • GSK Investigational Site

    Montreal, Quebec, H3G 1A4

  • GSK Investigational Site

    Montreal, Quebec, H3T 1E2

  • GSK Investigational Site

    Ottawa, Ontario, K1H 8L6

  • GSK Investigational Site

    Québec, Quebec, G1S 4L8

Other trials in Canada

About this study

Official title: A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently With Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women With Locally Advanced Breast Cancer

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.

Read the 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.

Being tested
doxorubicin + cyclophosphamide, paclitaxel + pazopanib, surgery, pazopanib monotherapy
Keywords
Neoadjuvant Breast Cancer, Pazopanib (GW786034), NSABP Foundation, Inc., cyclophosphamide, Paclitaxel, Doxorubicin
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • doxorubicin + cyclophosphamideDrug

    4 cycles of doxorubicin + cyclophosphamide followed by 4 cycles of paclitaxel + pazopanib.

  • paclitaxel + pazopanibDrug

    4 cycles of paclitaxel + pazopanib

  • surgeryProcedure or surgery

    neoadjuvant surgery for breast cancer

  • pazopanib monotherapyDrug

    6 months of treatment with pazopanib monotherapy

Study groups in NCT00849472
Study groupRoleWhat they receive
Treatment ArmExperimentalPreoperative Cycles 1-4 Doxorubicin 60 mg/m2 IV over 15 minutes + Cyclophosphamide 600 mg/m2 IV over 30 minutes of Day 1 every 21 days followed by: Cycles 5-8 Paclitaxel 80 mg/m2 IV over 60 minutes (Days 1, 8, and 15) every 28 days in combination with pazopanib (800 mg) PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning on Day 1 of the first paclitaxel cycle Until 7 days before surgery Followed by Surgery Postoperative Pazopanib 800 mg PO once daily (2 tablets taken at the same time each day either 1 hour before or 2 hours after a meal) Daily beginning 4-6 weeks after surgery 6 months from first postoperative dose
Receives: Drug: doxorubicin + cyclophosphamide; Drug: paclitaxel + pazopanib; Procedure: surgery; Drug: pazopanib monotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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)

Secondary outcomes (10)

  1. 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.

    Measured: 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)

  2. 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.

    Measured: From the start of the study until an average of 86.2 days (standard deviation of 5.76 days) after study entry

  3. 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.

    Measured: 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)

  4. 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.

    Measured: up to 24 months after study entry

  5. 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.

    Measured: 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)

  6. 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.

    Measured: 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).

  7. 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.

    Measured: 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)

  8. 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.

    Measured: up to 24 months after study entry

  9. Number of Participants With the Indicated Radiotherapy-related Complications

    Measured: up to 24 months after study entry

  10. 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.

    Measured: up to 24 months after study entry

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionDec 2011
  4. Study completionApr 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
101 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00849472
Sponsor's protocol ID
110264
Other IDs
NSABP FB-6
Status last verified
Dec 2013
First submitted
12 Feb 2009
Last updated
4 Mar 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing doxorubicin + cyclophosphamide, paclitaxel + pazopanib and surgery in people with Neoplasms, Breast, run by GlaxoSmithKline at 143 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Pathologic Complete Response (pCR) in the Breast and Nodes (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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849472.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2014.

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