Unique ID issued by UMIN | UMIN000012909 |
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Receipt number | R000014639 |
Scientific Title | A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer |
Date of disclosure of the study information | 2014/01/21 |
Last modified on | 2019/03/22 16:21:05 |
A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer(KBCSG-TR1315)
A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer(KBCSG-TR1315)
Japan |
HER2 negative operable breast cancer
Breast surgery |
Malignancy
NO
To evaluate the efficacy and safety of preoperative administration of Tri-weekly nanoparticle albumin-bound paclitaxel(nab-Paclitaxel) of 4 cycles followed by FEC of 4 cycles in patients with HER2 negative operable breast cancer.
Efficacy
Confirmatory
Pragmatic
Phase II
Pathological complete response rate
(1) Safety(adverse events, incidence of cardiac disorders)
(2) Overall response rate
(3) Breast conserving rate
(4) QpCR rate
(5) CpCR and pN0 rate
(6) SpCR rate
Interventional
Single arm
Non-randomized
Open -no one is blinded
Historical
1
Treatment
Medicine |
Administrate 4 cycles of FEC after 4 cycles of nab-Paclitaxel. Operation is to be performed after chemotherapy.
nab-Paclitaxel(260mg/m2) intravenously on day 1 of each 3-weeks.
FEC(5-Fluorouracil 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2) intravenously on day 1 of each 3-weeks.
20 | years-old | <= |
65 | years-old | >= |
Female
1) Primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy.
2) T1c-3, N0-1, M0 and tumor size is less than 7 cm.
3) Invasive lesion of the primary lesion is confirmed as HER2 negative (IHC 0-1+ or, if IHC 2+ -> FISH negative).
4) Enrollmental age between 20 years old and 65 years old.
5) ECOG performance status (PS):0-1
6) Results from a laboratory test meet the following :
- Neutrophil count is >=1,500/mm3
- Platelet >= 100,000/mm3
- Hemoglobin >= 10.0 g/dL
- AST <= 3 times of upper limit of normal (ULN)
- ALT <= 3 times of upper limit of normal (ULN)
- Total bilirubin < 1.5 mg/dL
- Creatinine < 1.5 mg/dL
7) No clinical abnormality by electrocardiography.
8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan.
9) Evaluate images of the primary lesion before and after treatment by CT, MRI. The evaluation must be conducted by the same modality (At an allergy for contrast media, the omission is permissible).
10) Evaluate images of the primary lesion before and after treatment by ultrasonic diagnosis. The evaluation must be conducted by the same modality
11) No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
12) Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy, radiation therapy.
13) Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy).
14) Signed written informed consent.
1) Hypersensitivity to any agents necessary in the planned treatment.
2) Poorly controlled complication.
3) Active infectious disease or Fever with suspected infection.
4) Symptoms of varicella.
5) Serious edema.
6) Serious peripheral neuropathy.
7) Positive for HBs antigen, except for not under the appropriate antiviral medication
8) Complication which requires prior pre-treatment with corticosteroid.
9) Previous history or receiving treatment of dementia or serious psychiatric disorder.
10) Heterochrony or synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
11) Active multiple cancer (Non-invasive tumor or disease free periods after treatment are more than two years, considered to be non-activity).
12) Treatment with anticancer agent within five years.
13) Ineligible based on decision of an investigator.
120
1st name | Norikazu |
Middle name | |
Last name | Masuda |
Osaka National Hospital
Department of Surgery, Breast Surgery
540-0006
1-14, 2-chome Hoenzaka, Chuo-ku, Osaka-city, Osaka, Japan
06-6942-1331
nmasuda@alpha.ocn.ne.jp
1st name | Takahiro |
Middle name | |
Last name | Nakayama |
Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
Adminstrative office
541-8567
3-1-69, Otemachi, chuou-ku, Osaka-city, Osaka, Japan
06-6945-1181
taqnakayama@hotmail.com
Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
The Supporting Center for Clinical Research and Education(SCCRE)
Non profit foundation
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NO
2014 | Year | 01 | Month | 21 | Day |
Unpublished
Completed
2013 | Year | 10 | Month | 17 | Day |
2014 | Year | 01 | Month | 20 | Day |
2014 | Year | 01 | Month | 21 | Day |
2019 | Year | 02 | Month | 28 | Day |
2014 | Year | 01 | Month | 21 | Day |
2019 | Year | 03 | Month | 22 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014639
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