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Trial record 13 of 1627 for:    Recruiting, Not yet recruiting, Available Studies | "Breast Diseases"

Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer

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ClinicalTrials.gov Identifier: NCT03373708
Recruitment Status : Not yet recruiting
First Posted : December 14, 2017
Last Update Posted : December 18, 2017
Sponsor:
Information provided by (Responsible Party):
Zhiyong Yu, Shandong Cancer Hospital and Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Chemotherapy Endocrine Breast Diseases Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Goserelin acetate Drug: Tamoxifen Drug: Letrozole Phase 2 Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 20, 2017
Estimated Primary Completion Date : December 20, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: EC follow T group
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
Drug: Epirubicin
100mg/m2
Other Name: Adriacin

Drug: Cyclophosphamide
600mg/m2
Other Name: Cyclophosphamide injection

Drug: Docetaxel
75mg/m2(TC), 100mg/m2(EC-T)
Other Name: Docetaxel injection

Experimental: TC follow endocrine
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
Drug: Cyclophosphamide
600mg/m2
Other Name: Cyclophosphamide injection

Drug: Docetaxel
75mg/m2(TC), 100mg/m2(EC-T)
Other Name: Docetaxel injection

Drug: Goserelin acetate
3.6mg every month
Other Name: Zoladex

Drug: Tamoxifen
10mg twice daily oral
Other Name: Nolvadex

Drug: Letrozole
2.5mg every daily oral
Other Name: Femara




Primary Outcome Measures :
  1. Disease-free survival (DFS) [ Time Frame: 5 years ]
    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 :
  1. Expression of female hormone levels [ Time Frame: 5 years ]
    To assess the association between the female hormone levels and the clinical outcomes

  2. Overall survival (OS) [ Time Frame: 5 years ]
    To determine the percentage of Overall survival (OS) for the EC follow T arm and TC follow endocrine therapy arm separately.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373708


Contacts
Contact: Zhiyong Yu, PhD 86-13355312277 drzhiyongyu@aliyun.com
Contact: Zhaoyun Liu, MD 86-17865123967 liuzhaoyun99@163.com

Sponsors and Collaborators
Zhiyong Yu
Investigators
Study Chair: Zhiyong Yu, PhD Shandong Cancer Hospital and Institute
Principal Investigator: Zhaoyun Liu, MD Shandong Cancer Hospital and Institute

Responsible Party: Zhiyong Yu, Director of the Breast Surgery Ⅰ, Shandong Cancer Hospital and Institute
ClinicalTrials.gov Identifier: NCT03373708     History of Changes
Other Study ID Numbers: ShandongCHI-03
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 18, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Diseases
Breast Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Cyclophosphamide
Docetaxel
Letrozole
Tamoxifen
Epirubicin
Goserelin
Phenobarbital
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists