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Locally Advanced (Stage III) Breast Cancer
WHAT WE ALREADY KNOW
Globally, locally advanced breast cancer (LABC) (Clinical stages IIB(T3) –IIIC is the most common presentation of this malignancy. In many low and middle income countries, one half to 90% of cases are first diagnosed when in these stages (For example data from rural Bangladesh accessible at agbreastcare.org). At present about two thirds of new breast cancer cases annually occur in low and middle income countries, and among poor women.
Even with state of the art (western high income country) treatment approaches, a majority of women with these presentations of disease die within five years, and the overwhelming majority of all women with LABC rarely get reasonable, comprehensive treatment. There is thus a significant need to define more effective and practical treatment for LABC.
The summary findings about treatment are that:
1. Neoadjuvant (i.e. first before any surgery) systemic chemotherapies can achieve complete responses with disappearance of all pathological evidence of cancer in LABC, which approach circumvents the growth-promoting effects on micro-metastases of sudden surgical removal of a primary tumor;
2. Very recent data are that higher rates of responses to treatment are associated with improved disease-free and overall survivals when both neoadjuvant chemotherapy and radiation therapy are used concurrently;
3. Significantly high disappearance of all cancer rates are suggested in primary tumors which are triple negative (that is have no evidence of estrogen, or progesterone receptors or Her-2/neu oncogene overexpression); together with the relatively low cost of certain useful and critical chemotherapy drugs, suggest that significantly better outcomes for women with LABC in low and middle income counties may now be possible.
THE BIG ISSUE
CAN A CONCURRENT CHEMOTHERAPY AND RADIATION THERAPY TREATMENT PROGRAM FOR LABC DEVELOPED IN THE UNITED STATES BE SUCCESSFULLY APPLIED IN DIFFERENT TREATMENT CIRCUMSTANCES IN SOUTHEAST ASIA AND ACHIEVE SIMILAR EXCELLENT RESULTS?
IBCRF investigators Dr. Rebecca Dent of the National University of Singapore, Dr. Silvia Formenti of New York University Cancer Center, Dr. Seema Khan of Northwestern University, and the IBCRF Scientific Director have proposed the following clinical trial and have assembled a group of investigators in 10 South and Southeast Asian countries to do this research:
A PHASE II RANDOMIZED STUDY OF PACLITAXEL AND CONCURRENT RADIATION THERAPY FOLLOWED BY SURGERY, VERSUS NEOADJUVANT CHEMOTHERAPY FOLLOWED BY SURGERY, IN WOMEN WITH ESTROGEN RECEPTOR (ER), PROGESTERONE RECEPTOR (PR), AND HER-2/NEU OVEREXPRESSION NEGATIVE (“TRIPLE NEGATIVE”), LOCALLY ADVANCED (T3) BREAST CANCER (LABC) [STAGES IIB (T3)-IIIC]
The objectives of this trial are:
In 310 women with stage IIB (T3)-IIIC locally advanced breast cancer (LABC), which is estrogen receptor and progesterone receptor protein negative and HER-2/neu negative (“Triple negative”):
PRIMARY OBJECTIVE: To determine whether those women randomized to receive treatment with: Treatment A: Neoadjuvant concurrent paclitaxel chemotherapy and radiation therapy, achieve a higher rate of pathological complete response (pCR) than Treatment B: Neoadjuvant paclitaxel followed by epirubicin (or doxorubicin)/cyclophosphamide chemotherapy.
SECONDARY OBJECTIVES: In patients randomized to the treatment A program (concurrent paclitaxel and radiation therapy, followed by mastectomy/ axillary dissection surgery, followed by epirubicin (or doxorubicin)/cyclophosphamide chemotherapy) and treatment B program (neoadjuvant chemotherapy with paclitaxel followed by epirubicin (or doxorubicin)/ cyclophosphamide, followed by mastectomy/axillary dissection surgery, followed by chest wall regional lymph node radiation therapy):
- A. To determine whether the overall three year survival (OS) rate is greater in treatment program A than in treatment program B.
- B. To determine whether the three year relapse-free survival (RFS) rate is greater in treatment program A than in treatment program B.
- C. To determine whether the complete clinical response (cCR) before surgery is greater with treatment A than with the treatment B .
- D. To evaluate association of pathological response -pCR alone and combined pCR and partial pathological response (pPR)- and 3 year RFS and OS.
- E. To evaluate the frequency of toxicities, particularly wound infections and lymphedema, associated with these two treatment approaches.
IBCRF is currently seeking clinical site funding to conduct this trial. We anticipate being able to get matching funds from sources in Singapore. This entire important trial can be conducted for approximately one quarter the cost of such research in the United States where it cannot be done in any event because patients do not have this LABC presentation very often.”
To learn more: Write to Dr. Richard Love at firstname.lastname@example.org