Clinical trial · Interventional
A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer
A Phase III Trial of Carboplatin as Adjuvant Chemotherapy Versus Observation in Triple Negative Breast Cancer With Pathologic Residual Cancer After Neoadjuvant Chemotherapy: POST-Neo Adjuvant Study
NCT01752686CI-TRIAL-00008744unknownPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is designed to investigate the efficacy of carboplatin, as a post-operative adjuvant chemotherapy for triple negative breast cancer patients who have pathologic residual cancer after the preoperative chemotherapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- carboplatin chemotherapy
- description
- 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.
- interventionNames
- Drug: carboplatin
- type
- NO_INTERVENTION
- label
- Observation arm
- description
- In this observation arm, patients should be follow up with regular interval without treatment.
Primary outcomes (1)
- measure
- Disease-free survival (DFS)
- timeFrame
- up to 3 years
- description
- To compare DFS between carboplatin and observation within non-pCR (complete remission) patients
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria:
* Clinical diagnosis of breast cancer
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:
1. Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
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 drugsReferences
Publications (0)
Data not yet available
No reference posted for this study.