12 veckors adjuvans dOcetaxel Plus trastuzumaB hos patienter med liten, nodnegativ, HER2-positiv bröstcancer (NYKTUR) (SOBER)
12 veckors adjuvans dOcetaxel Plus trastuzumaB hos patienter med tumörer ≤1 cm, nodnegativ, HER2-positiv bröstcancer (SOBER): en enkelgruppsarm, öppen, prospektiv, fas 2-studie
This phase II trial aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Many clinical trials has showed the superiority of combining trastuzumab to chemotherapy in the treatment of HER2 positive early breast cancer with tumor size ≥1cm or node metastasis.But in pT1n0m0 breast cancer patients, patients with HER2 positive tumor show worse prognosis than those with HER2 negative tumor.A short duration of trastuzumab administration contaminately with chemotherapy may have similar efficacy and lowerer toxiticy compared with standard one year therapy.Our study aims to study the efficacy and safety of 12 weeks adjuvant docetaxel plus trastuzumab in patients with tumors ≤1cm, node-negative, HER2-positive breast cancer.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, Kina, 200025
- Ruijin Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
Women aged ≥18 years
Have finished radical operation
Pathologically confirmed dignosis of infiltrating primary breast cancer
According to AJCC ,pT≤1cm, pN0,no evidence for metastasis
Operation specimens are available for ER, progesterone receptor (PR) and Her2 detection, patients should be Her2 positive tumor (3+ by IHC or FISH+ )
Has Eastern Cooperative Oncology Group (ECOG) Performance Score 0-1,expected survival time > 12 months
Adequate bone marrow function,adequate liver and renal function,and adequate coagulation function.
Women with potential child-bearing must have a negative pregnancy test (urine or serum) within 7 days of drug administration and agree to use an acceptable and effective method of contraception to avoid pregnancy during the study.
Written informed consent according to the local ethics committee requirements.
Exclusion Criteria:
pT>1cm or node positive
Metastatic breast cancer
Any prior systemic or loco-regional treatment of breast cancer, including chemotherapy in 28 days
With a history of malignant tumor except uterine cervix cancer in situ or skin basal cell carcinoma
Patients with medical conditions that indicate intolerant to adjuvant chemotherapy and related treatment, including severe infection, coagulation disorder,active peptic ulcer, coagulation disorder, connective tissue disease or myelo-suppressive disease
Has symptomatic peripheral neuropathy > grade 2 according to NCI
Known severe allergy to any drugs in this study
Has cadiac Dysfunction or lung dysfunction defined as follows:
- grade ≥3 CHF according to NCI CTCAE v 4.0 or NYHA≥II
- angina which requires drug control ,cardiac infraction,and any other vascular disease with apparent clinical symptoms
- uncontrolled high-risk arryhthmia
- unconrolled hypertension
Has active hepatitis B or hepatitis C with abnormal liver function tests (LFTs) or is known to be HIV positive
Patient is pregnant or breast feeding
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Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Experimental Arm
12 weeks adjuvant docetaxel plus trastuzumab |
Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles. Docetaxel 100mg/m2，d1，iv，q3w*4 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Disease-free Survival
Tidsram: 3-year estimates
|
Disease-free survival is defined as the time from the date of surgery to the first appearance of one of the following: breast cancer in situ or invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second (non-breast) invasive cancer, or death without cancer event; or censored at date of last follow-up. |
3-year estimates
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Breast Cancer Specific Survival
Tidsram: 3-year estimates
|
Defined as the time from the date of surgery to death from breast cancer relapse; or censored at date last known alive. |
3-year estimates
|
|
Overall Survival
Tidsram: 3-year estimats
|
Defined as the time from the date of surgery to death from any cause; or censored at date last known alive. |
3-year estimats
|
|
Treatment-related adverse events
Tidsram: up to 4 months
|
Incidence and severity of adverse events as assessed by NCI CTCAE V4.0 |
up to 4 months
|
|
Change of LVEF after treatment
Tidsram: up to 4 months
|
The change of LVEF after 12 weeks treatment compared to the baseline LVEF |
up to 4 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Li Zhu, doctor, Shanghai Jiao Tong University School of Medicine
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Aminosyror, peptider och proteiner
- Proteiner
- Organiska kemikalier
- Kolväten
- Cykloparaffiner
- Kolväten, alicyklisk
- Kolväten, cykliska
- Terpener
- Antikroppar, monoklonal, humaniserad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Taxoids
- Cyklodekaner
- Gentare
- Docetaxel
- Trastuzumab
Andra studie-ID-nummer
- RJBC1712
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
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