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Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics

2018. szeptember 13. frissítette: NYU Langone Health

Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.

**Surgery: Patients will undergo lumpectomy and axillary node dissection or modified radical mastectomy within two months following discontinuation of pre-operative systemic therapy, contingent upon recovery of skin toxicity. Pathologic response will be evaluated at the time of surgery. Additional tissue samples will be collected from the surgical specimen for assessment of tumor molecular characteristics.

***All patients may undergo four cycles of post-operative Standard AC (doxorubicin 60 mg/m2, cyclophosphamide 600 mg/m2) or four cycles of post-operative epirubicin and Cyclophosphamide (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) if doxorubicin is not available Tamoxifen as well or any alternative antihormonal therapy may be prescribed for five years for patients with hormone receptor positive tumors. Herceptin (Trastuzumab) will be prescribed for a total of 1 year since first dose as per standard of care.

A tanulmány áttekintése

Állapot

Megszűnt

Körülmények

Beavatkozás / kezelés

Részletes leírás

Locally Advanced Breast Cancer: T greater than 3.0 cm. HER-2/neu positive. Patients with ipsilateral supraclavicular nodes are eligible. Patients with inflammatory breast cancer or distant metastases are excluded. Patients with prior treatment for their breast cancer are excluded. Patients must have adequate laboratory parameters and normal cardiac function. Patients receive Concurrent Radiation therapy with either Capecitabine, Paclitaxel and Herceptin. Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be 2 mg/kg/week IV over 30 minutes. Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the completion of the radiation treatment until surgery and thereafter as per standard of care up to 1 year post surgery.

Tanulmány típusa

Beavatkozó

Beiratkozás (Tényleges)

44

Fázis

  • 2. fázis
  • 1. fázis

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi helyek

  • Egyesült Államok
    • New York
      • New York, New York, Egyesült Államok, 10065
        • Weill Medical College of Cornell University

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

18 év (Felnőtt, Idősebb felnőtt)

Egészséges önkénteseket fogad

Nem

Tanulmányozható nemek

Női

Leírás

Inclusion Criteria:

  • Biopsy proven locally advanced breast cancer: STAGE IIB (T must be > 3.0 cm, N0), IIIA (T0N2, T1N2, T2N2, T3N1), IIIB (T4N0-2).
  • HER-2/neu positive ( DAKO 3+ by Immunohistochemistry or FISH positive if Dako 2+)
  • Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes.
  • Measurable disease required according to the RECIST criteria (Response Evaluation Criteria in Solid Tumors)
  • Adequate laboratory values:
  • Hgb > 10
  • ANC(Absolute Neutrophil Count) > 1500
  • Platelets > 150,000
  • Cr < 1.5
  • Liver function < 3 X normal.
  • Patient > 18 years of age.
  • Medically and psychologically able to comply with all study requirements.
  • ECOG (Eastern cooperative Oncology group) performance score 0-1.
  • Signed informed consent.

Exclusion Criteria:

  • Stage 0, Stage I, Stage IIA.
  • Previous XRT(Radiation therapy) or chemotherapy.
  • Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes.
  • Inflammatory breast cancer.
  • Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
  • Exclude pregnant or lactating woman.
  • Woman of childbearing potential with either a positive or no pregnancy test at baseline.
  • Woman of childbearing potential not using a reliable and appropriate contraceptive method.
  • (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
  • Patient will agree to continue contraception for 30 days from the date of the last study drug administration.
  • Serious concurrent infections.
  • Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias ) or myocardial infarction within the last 12 months.
  • Patients who have had an organ allograft.
  • Patients with severe renal impairment (creatinine clearance below 30 mL/min [Cockcroft and Gault43]). In patients with moderate renal impairment (creatinine clearance 30-50 mL/min [Cockcroft and Gault43]) at baseline, a dose reduction to 75% of the XELODA starting dose is recommended. In patients with mild renal impairment (creatinine clearance 51-80 mL/min) no adjustment in starting dose is recommended.
  • In phase I studies, those with any abnormal renal function, since toxicity will likely be affected by the presence of any significant renal dysfunction.
  • Cockcroft and Gault Equation:
  • (140 - age [yrs]) (body wt [kg])
  • Creatinine clearance for males = --------------
  • (72) (serum creatinine [mg/dL])
  • Creatinine clearance for females = 0.85 x male value

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Nem véletlenszerű
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Nincs (Open Label)

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Kísérleti: Arm 1 Capecitabine and RT
Her-2/neu negative patients will be given Capecitabine (xeloda, 750mg/m2 twice daily orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).
Sugárzás: Radiation Therapy (RT)
Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.
Drog: Capecitabine
Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).
Más nevek:
  • Xeloda
Kísérleti: Arm 2 Paclitaxel/Trastuzumab and RT
Trastuzumab (Herceptin®) will begin on day 1 of radiation therapy and be administered weekly to Her-2/neu Positive patients. The first dose will be 4mg/kg given IV over 90 minutes. Weekly doses will be 2 mg/kg/week IV over 30 minutes.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour.
Sugárzás: Radiation Therapy (RT)
Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.
Drog: Trastuzumab
Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the completion of the radiation treatment until surgery and thereafter as per standard of care up to 1 year post surgery.
Más nevek:
  • Herceptin
Drog: Paclitaxel
Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with the first paclitaxel dose. If the patient tolerates the treatment, the dexamethasone may be tapered and/or discontinued for subsequent doses. Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks following radiation).
Más nevek:
  • Taxol
Kísérleti: Arm 3: Paclitaxel and RT
Paclitaxel 30 mg/m2 twice per week given IV over 1 hour to Her-2/neu negative patients. Treatment will be initiated during the first week of radiation therapy and should be administered on a Monday/Thursday or Tuesday/Friday schedule.
Sugárzás: Radiation Therapy (RT)
Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.
Drog: Paclitaxel
Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with the first paclitaxel dose. If the patient tolerates the treatment, the dexamethasone may be tapered and/or discontinued for subsequent doses. Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks following radiation).
Más nevek:
  • Taxol
Kísérleti: Arm 4: Paclitaxel/Trastuzumab and RT
Trastuzumab (Herceptin®) tx will be administered weekly, together with one of the 2 weekly doses of Paclitaxel to Her-2/neu Positive patients. The 1st dose will be 4mg/kg given IV over 90 minutes. Weekly doses will b given at a dose of 2 17mg/kg/week IV over 30 minutes. The Tx with Trastuzumab will continue weekly after the completion of the radiation tx until surgery & thereafter as per std of care up to 1 yr post surgery.Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Tx will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab.
Sugárzás: Radiation Therapy (RT)
Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.
Drog: Trastuzumab
Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the completion of the radiation treatment until surgery and thereafter as per standard of care up to 1 year post surgery.
Más nevek:
  • Herceptin
Drog: Paclitaxel
Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with the first paclitaxel dose. If the patient tolerates the treatment, the dexamethasone may be tapered and/or discontinued for subsequent doses. Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks following radiation).
Más nevek:
  • Taxol

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Időkeret
Feasibility & Efficacy of Chemo-radiation While Targeting Treatment, Based on: Original Tumor Characteristics; to be Followed by [Need for] Conventional Post-operative Chemotherapy
Időkeret: 12/2014 (up to 12 years)
12/2014 (up to 12 years)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
To Assess the Pathological Response Rate and Compare it to That Achieved in Our Previous Phase I-II Trials of Concurrent Chemo-radiation.
Időkeret: 12/2014 (up to 12 years)
No data displayed because Outcome Measure has zero total participants analyzed.
12/2014 (up to 12 years)
To Store Core Biopsies of the Original Tumor Before and After Treatment (From the Surgical Specimen) for Future Molecular Biology Studies in LABC.
Időkeret: 12/2014 (up to 12 years)
No data displayed because Outcome Measure has zero total participants analyzed.
12/2014 (up to 12 years)
To Acquire Descriptive Information on Patient Adherence to Therapy and on Quality of Life During Treatment.
Időkeret: 12/2014 (up to 12 years)
Data were not collected as PI left institution prior to enrollment completion. Planned Statistical analysis was not performed for this secondary outcome measure.
12/2014 (up to 12 years)

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

NYU Langone Health

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete

2002. június 1.

Elsődleges befejezés (Tényleges)

2014. december 2.

A tanulmány befejezése (Tényleges)

2014. december 2.

Tanulmányi regisztráció dátumai

Először benyújtva

2014. október 27.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2014. november 20.

Első közzététel (Becslés)

2014. november 21.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2018. október 15.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2018. szeptember 13.

Utolsó ellenőrzés

2018. szeptember 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

Kulcsszavak

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • 10289

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

Gyógyszer- és eszközinformációk, tanulmányi dokumentumok

Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz

Igen

Egy amerikai FDA által szabályozott eszközterméket tanulmányoz

Nem

az Egyesült Államokban gyártott és onnan exportált termék

Nem

Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .

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