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A Phase III,Randomized ,Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy


N/A
18 Years
70 Years
Not Enrolling
Female
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

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Trial Information

A Phase III,Randomized ,Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy


Individualized treatment of breast cancer has become one of the main directions in the
clinical and research areas of breast cancer,and the individualized treatment of the
estrogen receptor(ER) positive patients which covered 65% of total cases is of vital
importance. Historical research showed that among the ER-positive and HER2-negative breast
cancer,Luminal B breast cancer with Ki67>14% is more likely to be benefited from
chemotherapy,compared with the Luminal A breast cancer with Ki67<14%. And the results of our
previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in
Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence
whether switching to Anthracycline-based post operative protocol can benefit them.So
that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2
negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT
protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into
the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and
OS of two subgroup.


Inclusion Criteria:



- Chinese population surgery patients with invasive breast cancer;

- Stage II-III;

- ER positive;

- HER2 negative;

- Ki67≥14%;

- Aged between 18 and 70 years old;

- The maximum diameter of the primary tumor greater than 1cm;

- ECOG score 0-1 points; -Have adequate baseline bone marrow and organ function reserve
: absolute neutrophil count ≥ 1500/mm3, platelet count ≥ 8g/dl; the ≥ 100000/mm3
hemoglobin concentration and serum creatinine ≤ 1.5 times the upper limit of normal ;
aspartate aminotransferase and alanine aminotransferase ≤ 2.5 times the upper limit
of normal , bilirubin ≤ 1.5 times the upper limit of normal ; left ventricular
ejection fraction ( LVEF ) ≥ 50%

Exclusion Criteria: - Non - Chinese population of patients;

- Non- invasive cancer patients;

- Inflammatory Breast Cancer patients;

- Metastatic breast cancer patients;

- HER2 positive patients;

- Ki67<14% patients;

- No adequateBaseline bone marrow or organ function reserve;

- ECOG PS score ≥ 2 points;

- Younger than 18 years of age or greater than 70 years old;

- Already accepted therapy including chemotherapy , endocrine therapy or targeted
therapy before neoadjuvant treatment;

- HER2-positive patients with left ventricular ejection fraction less than 55 % can not
receiving Herceptin;

- Known allergy of docetaxel , capecitabine , epirubicin , ring phosphonamide .

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Disease free survival after adjuvant chemotherapy within five years

Outcome Description:

Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.

Outcome Time Frame:

Within 5 years after adjuvant chemotherapy

Safety Issue:

Yes

Principal Investigator

Liao Ning, MD,PhD

Investigator Role:

Study Director

Investigator Affiliation:

Guangdong Academy of Medical Sciences

Authority:

China: Ethics Committee

Study ID:

GGHBCRG

NCT ID:

NCT01779531

Start Date:

January 2013

Completion Date:

June 2015

Related Keywords:

  • Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
  • HER2-negative Luminal B breast cancer
  • Breast Neoplasms
  • Carcinoma

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