tially to ACP chemotherapy in patients with HER2 positive early breast cancer following surgery.
- The BCIRG 006 study was designed to investigate combining Herceptin treatment with docetaxel either following AC chemotherapy or in combination with docetaxel and carboplatin in patients with HER2 positive early breast cancer following surgery.
Early breast cancer in the HERA trial was limited to operable, primary, invasive adenocarcinoma of the breast, with axillary nodes positive or axillary nodes negative if tumours at least 1 cm in diameter.
In the joint analysis of the NCCTG N9831 and NSABP B-31 studies, early breast cancer was limited to women with operable breast cancer at high risk, defined as HER2-positive and axillary lymph node positive or HER2 positive and lymph node negative with high risk features (tumour size > 1 cm and ER negative or tumour size > 2 cm, regardless of hormonal status).
In the BCIRG 006 study HER2 positive, early breast cancer was defined as either lymph node positive or high risk node negative patients with no (pN0) lymph node involvement, and at least 1 of the following factors: tumour size greater than 2 cm, estrogen receptor and progesterone receptor negative, histological and/or nuclear grade 2-3, or age < 35 years).
The efficacy results from the HERA trial are summarized in the following table:
|
Parameter
|
Observation
N=1693
|
Herceptin 1 Year
N = 1693
|
P-value vs
Observation
|
Hazard Ratio vs
Observation
|
|
Disease-free survival
|
|
|
|
|
|
- No. patients with event
|
219 (12.9 %)
|
127 (7.5 %)
|
< 0.0001
|
0.54
|
|
- No. patients without event
|
1474 (87.1 %)
|
1566 (92.5 %)
|
|
|
|
Recurrence-free survival
|
|
|
|
|
|
- No. patients with event
|
208 (12.3 %)
|
113 (6.7 %)
|
< 0.0001
|
0.51
|
|
- No. patients without event
|
1485 (87.7 %)
|
1580 (93.3 %)
|
|
|
|
Distant disease-free survival
|
|
|
|
|
|
- No. patients with event
|
184 (10.9 %)
|
99 (5.8 %)
|
< 0.0001
|
0.50
|
|
- No. patients without event
|
1508 (89.1 %)
|
1594 (94.2 %)
|
|
|
Study BO16348 (HERA): 12 months follow-up
For the primary endpoint, DFS, the hazard ratio translates into an absolute benefit, in terms of a 2-year disease-free survival rate, of 7.6 percentage points (85.8 % vs 78.2 %) in fa |
