Neoadjuvant Endocrine Therapy in Breast Cancer

NCT03397537 | Completed Phase 2

• 1 other identifier: 20170811
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to compare the duration to complete or partial response (CR/PR) and the overall response rates (ORR) after six months of neoadjuvant endocrine therapy between pre-menopausal group and post-menopausal group with highly endocrine responsive operable mammary carcinoma.

Conditions

Highly Endocrine Responsive Operable Breast Cancer

Keywords

Breast Neoplasms Endocrine-responsive Neoadjuvant Duration Letrozole

Outcome Measures

Primary Outcomes (1)

• ORR

  overall response rate

  six months

Study Arms (2)

the postmenopausal

OTHER

2.5 mg letrozole every day for six months

Drug: Letrozole 2.5Mg Tablet

the premenopausal

EXPERIMENTAL

2.5 mg letrozole daily along with a GnRH analogue for ovarian suppression, which was administered as an intramuscular injection of 3.75 mg triptorelin every 28 days for 6 months.

Drug: Letrozole 2.5Mg Tablet; Drug: GnRH analogue

Interventions

Letrozole 2.5Mg Tablet DRUG

letrozole 2.5mg p.o.qd

the postmenopausal; the premenopausal

GnRH analogue DRUG

3.75 mg triptorelin im. q28d

the premenopausal

Eligibility Criteria

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

You may qualify if:

• Females ≥18 years
• ER-positive (≥50%), PgR-positive (≥50% ), HER2-negative, and previously untreated, non-metastatic primary invasive BC.
• The tumour size had to be \>1 cm.

You may not qualify if:

• male patients;
• patients with inflammatory breast cancer or distant metastasis;
• patients who were previously treatment treated with chemotherapy, radiation therapy or prior treatment with AIs or antiestrogens for breast cancer;
• patients with a second concomitant neoplasm;
• patients who could not meet the eligibility criteria.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Minyi Cheng

Guanzhou, Guangdong, 510080, China

Location

MeSH Terms

Interventions

Letrozole; Tablets; Gonadotropin-Releasing Hormone

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Dosage Forms; Pharmaceutical Preparations; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2017
• First Posted: January 12, 2018
• Study Start: September 1, 2012
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 17, 2018

Record last verified: 2012-09

Locations

CN (1)