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

NCT03373708 | Unknown Phase 2

• 1 other identifier: ShandongCHI-03
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Chemotherapy; Endocrine Breast Diseases

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS)

  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 Outcomes (2)

• Expression of female hormone levels

  5 years

• Overall survival (OS)

  5 years

Study Arms (2)

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

Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 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

Drug: Cyclophosphamide; Drug: Docetaxel; Drug: Goserelin acetate; Drug: Tamoxifen; Drug: Letrozole

Interventions

Epirubicin DRUG

100mg/m2

Also known as: Adriacin

EC follow T group

Cyclophosphamide DRUG

600mg/m2

Also known as: Cyclophosphamide injection

EC follow T group; TC follow endocrine

Docetaxel DRUG

75mg/m2(TC), 100mg/m2(EC-T)

Also known as: Docetaxel injection

EC follow T group; TC follow endocrine

Goserelin acetate DRUG

3.6mg every month

Also known as: Zoladex

TC follow endocrine

Tamoxifen DRUG

10mg twice daily oral

Also known as: Nolvadex

TC follow endocrine

Letrozole DRUG

2.5mg every daily oral

Also known as: Femara

TC follow endocrine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhiyong Yu: lead

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Interventions

Epirubicin; Doxorubicin; Cyclophosphamide; Docetaxel; Goserelin; Tamoxifen; Letrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Zhiyong Yu, PhD

  Shandong Cancer Hospital and Institute

  STUDY CHAIR

• Zhaoyun Liu, MD

  Shandong Cancer Hospital and Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhiyong Yu, PhD

CONTACT

86-13355312277; drzhiyongyu@aliyun.com

Zhaoyun Liu, MD

CONTACT

86-17865123967; liuzhaoyun99@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Breast Surgery Ⅰ

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 14, 2017
• Study Start: December 20, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: December 18, 2017

Record last verified: 2017-12