Description:
Breast cancer is the most common female malignancy in the world, and the leading cause of
cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the
main prognostic factor for breast cancer patients. Breast cancer subtype was defined by ER,
PR, HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer. Breast
cancer which ER are positive have less aggressive and better long-term prognoses than other
breast cancer subtype. Luminal B1 was definited as ER Positive, PR positive <20%, or Ki-67
≥20% , and HER2-Negative. Although standard therapy to HR positive breast cancer is endocrine
treatment, evidence reported that Luminal B1 breast cancers with lower PR expression are less
sensitive to tamoxifen than luminal A breast cancers with higher PR expression, and the
specific mechanism is not clear. We previously had a clinically analysed, and we found the
Luminal B1 breast cancer had a significant proportion with 38%. Whether we need standard
chemotherapy or chemotherapy based intensive endocrine therapy for those patients? In our
research, we divided the patients with ER positive, PR negative, and HER-2 negative into two
groups. One groups will be treated with 8 cycles of chemotherapy (EC×4-T×4). The other
received 4 cycles of chemotherapy (TC×4) then will be given the intensive endocrine therapy
(Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). The
primary endpoint is to assess disease-free survival (DFS) and overall survival (OS) in
different regiments, the secondary endpoint is to assess the expression of female hormone
levels. The correlation of the expression of female hormone levels with the clinical
outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal
B1 breast cancer.
Title
- Brief Title: Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
- Official Title: Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer
Clinical Trial IDs
- ORG STUDY ID:
ShandongCHI-03
- NCT ID:
NCT03373708
Conditions
- Breast Cancer
- Chemotherapy
- Endocrine Breast Diseases
Interventions
| Drug | Synonyms | Arms |
|---|
| Epirubicin | Adriacin | EC follow T group |
| Cyclophosphamide | Cyclophosphamide injection | EC follow T group |
| Docetaxel | Docetaxel injection | EC follow T group |
| Goserelin acetate | Zoladex | TC follow endocrine |
| Tamoxifen | Nolvadex | TC follow endocrine |
| Letrozole | Femara | TC follow endocrine |
Purpose
Breast cancer is the most common female malignancy in the world, and the leading cause of
cancer-associated mortalities among women. Hormone receptors (HR) including ER and PR are the
main prognostic factor for breast cancer patients. Breast cancer subtype was defined by ER,
PR, HER2 and Ki67 status since the definition of intrinsic subtypes for breast cancer. Breast
cancer which ER are positive have less aggressive and better long-term prognoses than other
breast cancer subtype. Luminal B1 was definited as ER Positive, PR positive <20%, or Ki-67
≥20% , and HER2-Negative. Although standard therapy to HR positive breast cancer is endocrine
treatment, evidence reported that Luminal B1 breast cancers with lower PR expression are less
sensitive to tamoxifen than luminal A breast cancers with higher PR expression, and the
specific mechanism is not clear. We previously had a clinically analysed, and we found the
Luminal B1 breast cancer had a significant proportion with 38%. Whether we need standard
chemotherapy or chemotherapy based intensive endocrine therapy for those patients? In our
research, we divided the patients with ER positive, PR negative, and HER-2 negative into two
groups. One groups will be treated with 8 cycles of chemotherapy (EC×4-T×4). The other
received 4 cycles of chemotherapy (TC×4) then will be given the intensive endocrine therapy
(Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal patients). The
primary endpoint is to assess disease-free survival (DFS) and overall survival (OS) in
different regiments, the secondary endpoint is to assess the expression of female hormone
levels. The correlation of the expression of female hormone levels with the clinical
outcomes, so that the investigators could optimize adjuvant treatment regiment with luminal
B1 breast cancer.
Detailed Description
The trial is designed to investigative the risk and clinical benefit of chemotherapy and
intensive endocrine therapy for Luminal B1 early-staged breast cancer. In this trial the
investigators will randomly assign 200 primary breast cancer patients to receive four cycles
of epirubicin and cyclophosphamide (EC) followed by four cycles of docetaxel(T), or four
cycles of docetaxel and cyclophosphamide (TC) followed by intensive endocrine therapy
(Goserelin acetate+Tamoxifen/Letrozole for young patients) . Patients with HER-2 positive was
excluded. The patient's conditions will be assessed before, and after every four cycles of
adjuvant chemotherapy to determine if there is any progression of the disease. The patient's
conditions will be assessed every three months when they received the intensive endocrine
therapy (Goserelin acetate+Tamoxifen for young patients/Letrozole for postmenopausal
patients). Patients will be followed up for DFS and OS in different regiments, the secondary
endpoint is to assess the expression of female hormone levels. The correlation of the
expression of female hormone levels with the clinical outcomes, so that the investigators
could optimize adjuvant treatment regiment with luminal B1 breast cancer.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| EC follow T group | Experimental | Epirubicin 100mg/m2 on day 1 cyclophosphamide 600mg/m2 on day1 every 2 weeks for four cycles followed by docetaxel 100mg/m2 on day 1 every 3 weeks for four cycles | - Epirubicin
- Cyclophosphamide
- Docetaxel
|
| TC follow endocrine | Experimental | Docetaxel 75mg/m2 on day 1 and cyclophosphamide 600mg/m2 on day 1 every 3 weeks for four cycles followed by goserelin acetate+tamoxifen for young patients/ letrozole for postmenopausal patients | - Cyclophosphamide
- Docetaxel
- Goserelin acetate
- Tamoxifen
- Letrozole
|
Eligibility Criteria
Inclusion Criteria:
- All patients were required to give written informed consent.
- Patients present with operable breast cancers that were diagnosed by histopathology
and have no distant metastasis.
- Have no history of anti-cancer therapies including chemotherapy, radiation therapy,
hormone therapy and surgical therapy
- Have normal cardiac functions by echocardiography
- ECOG scores are ≤ 0-1.
- Patients are disposed to practice contraception during the whole trial.
- The results of patients' blood tests are as follows:
Hb ≥ 90 g/L WBC ≥ 3.0×109/L Plt ≥ 100×109/L Neutrophils ≥ 1.5×109/L ALT and AST ≤ 2.5 times
of normal upper limit. TBIL ≤ 1.5 times of normal upper limit. Creatinine ≤ 1.5 times of
normal upper limit.
- ER+ Her2- early-stage breast cancer
Exclusion Criteria:
- Have other cancers at the same time or have the history of other cancers in recent
five years, excluding the controlled skin basal cell carcinoma or skin squamous cell
carcinoma or carcinoma in situ of cervix.
- Active infections
- Severe non-cancerous diseases.
- The patients are undergoing current administration of anti-cancer therapies, or are
attending some other clinical trails.
- Inflammatory breast cancer.
- Pregnant or lactational, or patients refuse to practice contraception during the whole
trial.- Page 5 of 5 -
- The patients are in some special conditions that they can't understand the written
informed consent, such as they are demented or hawkish.
- Have allergic history of the chemotherapeutic agents.
- Bilateral breast cancers
| Maximum Eligible Age: | 70 Years |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Disease-free survival (DFS) |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | To determine the percentage of disease-free survival (DFS) for the EC follow T arm and TC follow endocrine therapy arm separately. |
Secondary Outcome Measures
| Measure: | Expression of female hormone levels |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | To assess the association between the female hormone levels and the clinical outcomes |
| Measure: | Overall survival (OS) |
| Time Frame: | 5 years |
| Safety Issue: | |
| Description: | To determine the percentage of Overall survival (OS) for the EC follow T arm and TC follow endocrine therapy arm separately. |
Details
| Phase: | Phase 2/Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Unknown status |
| Lead Sponsor: | Zhiyong Yu |
Last Updated
December 18, 2017
