A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
NCT ID: NCT01752686
Last Updated: 2012-12-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
587 participants
INTERVENTIONAL
2013-03-31
2018-03-31
Brief Summary
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Detailed Description
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In POST Neo-adjuvant period
Randomization:
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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carboplatin chemotherapy
At the time of post neo-adjuvant period, the patients will be assigned to each treatment group in a 1:1 ratio i.e. carboplatin AUC 6 group vs. observation group. Six cycles of carboplatin (AUC=6) on the first day of every 21 days.
carboplatin
carboplatin as adjuvant chemotherapy
Observation arm
In this observation arm, patients should be follow up with regular interval without treatment.
No interventions assigned to this group
Interventions
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carboplatin
carboplatin as adjuvant chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Female patients
2. Histologically confirmed invasive breast cancer
1. Primary tumor greater than 2cm diameter, measured by mammography and sonography
2. Any N
3. ER (estrogen receptor)/ PR (progesterone receptor) / HER2 (negative/ negative/ negative)(ER \<1%, PR\<1%, IHC 0, 1+ or FISH - in case of IHC (immuno-histochemistry) 2+)
4. No evidence of metastasis (M0)
5. No prior hormonal, chemotherapy or radiotherapy is allowed.
6. No breast operation other than biopsy to make diagnosis is allowed.
7. Age: 20-years and older, not pregnant pre-, and postmenopausal women with good performance status (ECOG 0-1)
8. Adequate hematopoietic function: Absolute granulocyte count 1500/mm3, platelet 100,000/mm3, Hemoglobin 10 g/mm3
9. Adequate renal function: Serum creatinine 1.5 mg/dl
10. Adequate hepatic function: total bilirubin: 1.5 mg/dl, AST(aspartate aminotransferase)/ALT (alanine transaminase): 2 times normal, Alkaline phosphatase:2 times normal
11. Written informed consent
12. Normal mental function to understand and sign the consent
13. Cardiac function: normal or nonspecific EKG taken within 1 mo of enrollment.
14. LVEF (left ventricular ejection fraction)50% by MUGA (multiple gated acquisition scan) or Echocardiogram taken within 1 mo of enrollment
Exclusion Criteria
2. Patients who underwent surgery for breast cancer
3. Patients with a history of uncompensated congestive heart failure
4. Patients with inflammatory breast cancer (T4d)
5. Patients without primary tumor (T0)
6. Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
7. Known hypersensitivity to any of the study drugs
20 Years
FEMALE
No
Sponsors
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Severance Hospital
OTHER
Responsible Party
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Byeong Woo Park
Principal Investigator
Principal Investigators
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Byeong Woo Park, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Severance Hospital
Central Contacts
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Other Identifiers
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DA-TNBC
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Severance_BR_01
Identifier Type: -
Identifier Source: org_study_id