| Clinical
Trial: |
S9927
-- Post-Mastectomy Radiotherapy |
| Governing Group: |
Southwest Oncology
Group |
| Title: |
"A Randomized
Trial of Post-Mastectomy Radiotherapy in Stage II Breast Cancer in
Women with One to Three Positive Axillary Nodes." |
Eligibility:
- Confirmed adenocarcinoma of the breast.
- Primary tumor 2-5 cm and 1-3 positive axillary lumph nodes
(pathologic T1-2, Pathologic N1).
- Lymph nodes positive by cytokeratin staining only are not eligible.
- Pathologic N2 or N3, pathologic T3, pathologic or clinical
T4, or M1 disease.
- No apocrine, adenocystic, or squamous carcinomas or sarcomas
of the breast.
- No bilateral breast cancer.
- Patients must have undergone modified radical mastectomy sparing
the pectorialis minor muscle with level I and II +/- III axillary
dissection.
- Minimum 10 nodes removed and examined.
- Negative surgical margins for both invasive carcinoma and non-invasive
ductal carcinoma.
- No clinically matted nodes, gross extracapsular disease or
residual disease in the axilla.
- Microscopic extracapsular extension (ECE) is allowed.
- Patients with mastectomy after local failure following lumpectomy
are not eligible.
- No active local-regional disease.
- Patients may be registered either prior to or during administration
of hormonal therapy.
- Radiation must begin within eight (8) months after mastectomy
and should be planned to begin within six (6) weeks of completing
systemic chemotherapy.
- Registration to another adjuvant chemotherapy or hormonal therapy
trial is allowed, if allowed by that trial.
- Hormonal therapy (if prescribed) may be delivered concurrent
with radiation or may have already begun.
- No prior trastuzumab (herceptin) therapy.
- No other prior chemotherapy, except for treatment of current
breast cancer.
- No prior chest wall or nodal radiation therapy.
- At least 21 years of age.
- Radiation consult to be completed prior to registration.
|
| Clinical
Trial: |
N9831
- HER-2 Overexpressing Node Positive Breast Cancer |
| Governing Group: |
Southwest Oncology
Group |
| Title: |
"A Phase III
Trial of Doxorubicin and Cyclophosphamide (AC) Followed by Weekly
Paclitaxel with or without Trastuzumab as Adjuvant Treatment for Women
with HER-2 Overexpressing Node Positive Breast Cancer." |
Eligibility:
- Operable, histologically confirmed breast adenocarcinoma with
positive lymph nodes (either by axillary node dissection or sentinel
node finding).
- One or more positive nodes whose tumors are T1-3, pN1-2, M0.
- No cN2.
- No locally advanced tumors (T4) or peau d' orange.
- No bilateral invasive carcinoma and/or DCIS.
- Metaplastic carcinoma is acceptable.
- No prior therapy for breast cancer.
- No active cardiac disease.
- ER/PgR determination required.
- HER-2 positive.
- greater than/= 84 days from mastectomy or from axillary dissection
or sentinel node detection.
- No evidence of gross or microscopic tumor at the surgical resection
margins.
- No gross residual adenopathy.
- May have received up to four (4) weeks of tamoxifen or other
hormonal agen.
- May have received tamoxifen or raloxifen for chemotherapy protection,
but must be discontinued.
- Must be at least 18 years of age.
- Adequate hematologic, renal and hepatic function.
- Normal LVEF.
- Any hormonal treatment must be discontinued.
- Patients with breast conserving surgery or with mastectomy
and ./= four (4) positive nodes must plan radiation following
completion of chemotherapy.
- No sensitivity to benzyl alcohol.
- No neurology/neuropathy-sensory toxicities ./= Grade 2 per
NCI CTC.
|
