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A Prospective, Open and Unicentric Phase II Clinical Trial of Docetaxel Combined With Oxaliplatin for Triple Negative Local Advanced Breast Cancer Patients (TNLABC)

18 Years
65 Years
Open (Enrolling)
Triple Negative Local Advanced Breast Cancer

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Trial Information

A Prospective, Open and Unicentric Phase II Clinical Trial of Docetaxel Combined With Oxaliplatin for Triple Negative Local Advanced Breast Cancer Patients (TNLABC)

Eligibilty Female adults(>18 years old) were eligible if they had histologically or
cytologically confirmed stage IIIb or IIIc TNLABC that had not been treated with any
systemic treatment. Patients also had Eastern Cooperative Oncology Group(ECOG) Performance
status of 0 or 1, absolute neutrophil count (ANC)>1500/mm3,hemoglobin >8.0g/dL, and platelet
count >100,000/mm3,creatinine<2.5 times the upper limit of normal(ULN)), transaminases<2.5
times ULN or alkaline phosphatase<4 times ULN if transaminases was normal, and total
bilirubin <2.5 times ULN. Exclusion criteria were active infection, pregnancy, other primary
malignancy (except in situ carcinoma of cervix or adequately treated nonmelanomatous
carcinoma of the skin), any documented distant metastasis and uncontrolled systemic

This study protocol was approved by institutional ethic review boards and conducted
according to guidelines for good clinical practice and the Helsinki Declaration.All patients
provided written informed consent.

Study design and treatment plan This was a prospective, open and unicentric phase II
clinical study. All chemotherpy was administered intravenously on an outpatient basis. The
patients received dexamethasone 7.5mg orally twice a day for 3 days before the day of
chemotherapy. On day 1, docetaxel 75mg/m2 was infused over 60 minutes as well as oxaliplatin
130mg/m2 was infused over 120 minutes on day 2. Thirty minutes before chemotherapy,
premedication consisted of a 5-hydroxytryptamine3(HT3) receptor antagonist. Furthermore,
Vitamin C 2g and Vitamin B2 200mg were followed immediately after the chemotherapy.
Treatment was administered every 21 days for a maximum of four cycles or until disease
progression or unacceptable toxicity.The prophylactic use of a colony-stimulating factor
(CFS) was not permitted in the first cycle.

An initial diagnosis of unilateral primary breast cancer without distant metastases, at
least 7 months of follow-up information for disease recurrence and death and triple receptor
negative for estrogen receptor (ER), progesterone receptor (PR), Her2 were included as
pre-treatment evaluation. Moreover tumor size, number of involved axillary lymph nodes
(ALN), clinical stage and biomarkers such as Cathepsin-D, P53, nm23, PS2 and PCNA, were
recorded as available information for further analysis. In the procedure of neoadjuvant
chemotherapy, weekly or biweekly complete blood cell counts, physical examination,
electrocardiogram (EKG), liver and rental function tests should be repeated. Tumor size was
assessed by magnetic resonance imaging (MRI) every two cycles or when the clinical signs
suggested disease progression as well as before the chemotherapy. Tumor response was
determined by response evaluation criteria in solid tumors (RECIST). Complete and partial
response (CR and PR) should be confirmed on two assessments performed at least four weeks

Inclusion Criteria:

1. Women aged from 18 to 65 years;

2. Histologically or cytologically proven invasive unilateral breast cancer (regardless
of the type);

3. Initial clinical condition compatible with complete initial resection;

4. No residual macro or microscopic tumor after surgical excision;

5. Patient presenting one of the following criteria (reviewed before randomization by
referent pathologist):

Triple Negative(ER-PR-Her-2-) Hormone receptor negativity is defined as ER<10%,
PR<10% (IHC), HER2 negativity is defined as IHC 0-1+, or [IHC 2+ and FISH or CISH

6. No clinically or radiologically detectable metastases (M0);

7. No peripheral neuropathy > 1;

8. WHO Performance status (ECOG) of 0 or 1;

9. Adequate hematological function (neutrophil count ³ 2x109/l, platelet count ³ 100x
109/l, Hemoglobin > 9 g/dl);

10. Adequate hepatic function: ASAT and ALAT £ 1.5 ULN alkaline phosphatases £ 2.5
ULN,total bilirubin £ 1,5 ULN;

11. Adequate renal function: serum creatinine £ 1.5 ULN;

12. Patients accepting contraception intake during the overall length of treatment if of
childbearing potential;

13. Adequate cardiac function, LEVF value > 50% by Muga scan or echocardiography;

14. Signed written informed consent.

Exclusion Criteria:

1. Bilateral breast cancer or patient with controlateral DCIS;

2. Any metastatic impairment, including homolateral sub-clavicular node
involvement,regardless of its type;

3. Any tumor ³ T4a (UICC1987) (cutaneous invasion, deep adherence, inflammatory breast

4. Luminal A, Luminal B and Her-2 overexpression

5. Any clinically or radiologically suspect and non-explored damage to the controlateral

6. Previous cancer (excepted cutaneous baso-cellular epithelioma or uterine peripheral
epithelioma) in the preceding 5 years, including invasive controlateral breast

7. Patients already included in another therapeutic trial involving an experimental

8. Patients with other concurrent severe and/or uncontrolled medical disease or
infection which could compromise participation in the study;

9. LEVF < 50% (MUGA scan or echocardiography);

10. Clinically significant cardiovascular disease (e.g. unstable angina, congestive heart
failure, uncontrolled hypertension (>150/90), myocardial infarction or cerebral
vascular accidents) within 6 months prior to randomization;

11. Known prior severe hypersensitivity reactions to agents in this study

12. Women of childbearing potential who are unwilling or unable to use an acceptable
method to avoid pregnancy for the entire study period and up to 8 weeks after
treatment completion;

14) Women who are pregnant or breastfeeding. Adequate birth control measures should be
taken during study treatment phase; 15) Women with a positive pregnancy test en enrollment
or prior to study drug administration; 16) Patients with any psychological, familial,
sociological or geographical condition potentially hampering compliance with the study
protocol and follow-up schedule; those conditions should be discussed with the patient
before registration in the trial; 17) Individual deprived of liberty or placed under the
authority of a tutor.

Type of Study:

Expanded Access

Study Design:



United States: Food and Drug Administration

Study ID:

Fudan TNBC Neo CT



Start Date:

Completion Date:

Related Keywords:

  • Triple Negative Local Advanced Breast Cancer
  • triple negative local advanced breast cancer(TNLABC),neoadjuvant chemotherapy
  • Breast Neoplasms