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

December 14, 2017 updated by: Zhiyong Yu

Prospective Randomized Controlled Study on the Risk and Clinical Benefit of Chemotherapy and Intensive Endocrine Therapy for Luminal B1 Early-stage Breast Cancer

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.

Study Overview

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

Enrollment (Anticipated)

200

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
100mg/m2
Other Names:
  • Adriacin
600mg/m2
Other Names:
  • Cyclophosphamide injection
75mg/m2(TC), 100mg/m2(EC-T)
Other Names:
  • 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
600mg/m2
Other Names:
  • Cyclophosphamide injection
75mg/m2(TC), 100mg/m2(EC-T)
Other Names:
  • Docetaxel injection
3.6mg every month
Other Names:
  • Zoladex
10mg twice daily oral
Other Names:
  • Nolvadex
2.5mg every daily oral
Other Names:
  • Femara

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Expression of female hormone levels
Time Frame: 5 years
To assess the association between the female hormone levels and the clinical outcomes
5 years
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.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Zhaoyun Liu, MD, Shandong Cancer Hospital and Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 20, 2017

Primary Completion (Anticipated)

December 20, 2019

Study Completion (Anticipated)

December 20, 2019

Study Registration Dates

First Submitted

December 11, 2017

First Submitted That Met QC Criteria

December 11, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 18, 2017

Last Update Submitted That Met QC Criteria

December 14, 2017

Last Verified

December 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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