Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics
| Status: | Terminated |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 10/17/2018 |
| Start Date: | June 2002 |
| End Date: | December 2, 2014 |
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.
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.
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.
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.
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
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Weill Medical College of Cornell University Founded in 1898, and affiliated with what is now...
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