Neoadjuvant Chemotherapy of 6 Cycles vs 8 Cycles in Node Positve Breast Cancer

Conditions

Breast Cancer

Keywords

breast cancer, neoadjuvant, different number of chemotherapy cycles

Brief summary

Various regimens and schedule as neoadjuvant chemotherapy regimens were investigated and sequential treatment of anthracyclines followed by taxanes, which has shown superior pathologic complete respone (pCR) rate (NSABP-B27 study) is widely used until now. Considering the proven efficacy and tolerable toxicity of 3 cycles of FEC followed by 3 cycles of Docetaxel (FEC3-D3) compared to FEC 6 cycles in adjuvant chemotherapy (PACS 01 trial), use of FEC3-D3 regimen in neoadjuvant setting will be feasible with acceptable efficacy and further reduce the duration of neoadjuvant chemotherapy.

Detailed description

To investigate feasibility of FEC3-D3 regimen in neoadjuvant setting in terms of comparable efficacy and shorter duration across all subtypes.

Hwang I, Kim JE, Jeong JH, Ahn JH, Jung KH, Son BH, Kim HH, Shin J, Lee HJ, Gong G, Kim SB.

2023-06-263 citations

10.1007/s10549-023-06971-7

Abstract PS13-07: Neoadjuvant adriamycin plus cyclophosphamide followed by docetaxel (AC4-D4) vs 5-fluorouracil, epirubicin plus cyclophosphamide followed by docetaxel (FEC3-D3) in stage II or III operable breast cancer : Randomized phase III neo-shorter trial (NCT02001506)

Inhwan Hwang, Jeong Eun Kim, Jae Ho Jeong, Jin‐Hee Ahn, Kyung Hae Jung et al. (10 authors)

Cancer Research2021-02-15

10.1158/1538-7445.sabcs20-ps13-07

Abstract P1-02-14: Circulating cell-free DNA (CFD) measured by a simple fluorescent assay to predict relapse in triple negative breast cancer patients receiving neoadjuvant chemotherapy: A biomarker substudy of prospective observational study (NCT02001519, NCT02001506)

K Park, Margaret M. Woo, J-E Kim, J-H Ahn, Keun‐Hwa Jung et al. (6 authors)

Cancer Research2017-02-15

10.1158/1538-7445.sabcs16-p1-02-14

Abstract P1-14-15: A randomized phase lll trial of neoadjuvant sequential chemotherapy with 4 cycles of adriamycin plus cyclophosphamide followed by 4 cycles of docetaxel (AC4-D4) versus shorter 3 cycles of FEC followed by 3 cycles of docetaxel (FEC3-D3) in node-positive breast cancer (Neo-Shorter): First report of efficacy & toxicity profile

J-E Kim, J-H Ahn, Keun‐Hwa Jung, HJ Lee, Gong Gy et al. (13 authors)

Cancer Research2016-02-15

10.1158/1538-7445.sabcs15-p1-14-15

Interventions

DRUGFEC3-D3

Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks Docetaxel 75 mg/m2, every 3 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* Performance status 0 or 1 * Clinically stage 2 or 3 with histologically proven lymph node involvement * Tumor or lymph node greater than 1.5 cm

Exclusion criteria

* Pregnancy or lactation * Prior chemotherapy or radiotherapy for any malignancy * Documented history of cardiac disease contraindicating anthracyclines * Currently active infection

Design outcomes

Primary

Measure	Time frame
pathologic complete response (pCR) between two arms	within the first 30 days (plus or minus 3 days) after surgery

Secondary

Measure	Time frame	Description
3 year-disease free survival between two arms	3 year after surgery	1. Correlation of pCR and Ki-67 expression at baseline and D14 tumor specimen 2. 3 year-disease free survival 3. Correlation of pCR and biomarkers such as Ki-67 expression

Countries

South Korea

Outcome results

None listed