A Phase III Trial of Carboplatin as Adjuvant Chemotherapy in Triple Negative Breast Cancer

Yonsei University

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: carboplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01752686

Severance_BR_01

DA-TNBC (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

In Neo-adjuvant period Four cycles of 60 mg/m2 doxorubicin and 600 mg/m2 cyclophosphamide therapy at 3-week intervals followed by four cycles of 100 mg/m2 docetaxel at 3-week intervals.

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.

Enrollment: 587 estimated patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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587 participants in 2 patient groups

carboplatin chemotherapy

Experimental group

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.

Treatment:

Drug: carboplatin

Observation arm

No Intervention group

Description:

In this observation arm, patients should be follow up with regular interval without treatment.