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A Pre‐Operative Window Study Evaluating Denosumab, a RANKligand (RANKL) Inhibitor and Its Biological Effects in Young Premenopausal Women Diagnosed With Early Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Neoplasms

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Trial Information

A Pre‐Operative Window Study Evaluating Denosumab, a RANKligand (RANKL) Inhibitor and Its Biological Effects in Young Premenopausal Women Diagnosed With Early Breast Cancer

Inclusion Criteria:

1. Female gender

2. Age ≥ 18 years

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

4. Premenopausal status defined as the presence of active menstrual cycle or normal
menses during the 6 weeks preceding the start of study treatment. Biochemical
evidence of phase of menstrual cycle is required (estradiol, FSH and LH). In women
previously exposed to hysterectomy, premenopausal levels of estradiol, FSH and LH are
required to be eligible

5. Non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that

1. Histologically confirmed

2. Primary tumor size greater than 1.5 cm, measured by any of clinical examination,
mammography, ultrasound or magnetic resonance imaging

3. Any clinical nodal status

4. Fully operable and not fixed to chest wall.

6. Known HER2 status

7. Known estrogen receptor (ER) status and progesterone receptor status (PgR)

8. Patient has adequate bone marrow and organ function as shown by:

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L

- Platelets ≥ 100 x 109/L

- Hemoglobin (Hgb) ≥ 9.0 g/dL

- Serum creatinine ≤ 1.5 x ULN

- Total serum bilirubin ≤ 1.5 x ULN (in patients with known Gilbert Syndrome, a
total bilirubin ≤ 3.0 x ULN, with direct bilirubin ≤ 1.5 x ULN)

- AST and ALT ≤ 1.5 x ULN

- Random blood sugar (RBS) ≤ 200 mg/dL or ≤ 11.1 mmol/L

- Glycosylated hemoglobin (HbA1c) ≤ 8 %

9. Albumin-adjusted serum calcium ≥ 8.0 mg/dL (≥ 2.0 mmol/L)

10. Women of childbearing potential must agree to use an active local contraception
method for the duration of the study and for at least 7 months after the last dose of
study treatment

11. Patients must accept to take calcium and vitamin D supplementation until the
completion of the study treatment

12. Signed informed consent form (ICF) for all study procedures according to local
regulatory requirements prior to beginning of the study

13. Patients must accept to make available tumor and normal tissue samples for submission
to central laboratory at the Jules Bordet Institute, Brussels, Belgium, to conduct
translational studies as part of this protocol.

Exclusion Criteria:

1. History of any prior (ipsi and/or contralateral) breast cancer

2. Any "clinical" T4 tumor defined by TNM including inflammatory breast cancer

3. History of non-breast malignancies within the 5 years prior to study entry (except
carcinoma in situ of the cervix, of the colon, melanoma in situ and basal cell and
squamous cell carcinomas of the skin)

4. Prior or planned systemic anti-cancer therapy before definitive surgery

5. Unhealed or planned dental/oral surgery, current or previous osteonecrosis or
osteomyelitis of the jaw

6. Pregnant or lactating women or women of childbearing potential without a negative
serum or urinary pregnancy test within 7 days prior to starting study treatment;
irrespective of the method of contraception used

7. Active Hepatitis-B virus (HBV), Hepatitis-C virus (HCV) or human immunodeficiency
virus (HIV) infection

8. Known hypersensitivity to denosumab

9. Bilateral invasive tumors

10. Multifocal/multicentric tumors

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Geometric mean change in tumor Ki67 expression

Outcome Description:

Assessed by immunohistochemistry (IHC) from

Outcome Time Frame:

Baseline and surgery at Day 10

Safety Issue:


Principal Investigator

Martine J Piccart, Prof.

Investigator Role:

Study Chair

Investigator Affiliation:

Jules Bordet Institute


Belgium: Federal Agency for Medicinal Products and Health Products

Study ID:

IJB‐BCTL‐ 20119167



Start Date:

June 2013

Completion Date:

January 2015

Related Keywords:

  • Breast Neoplasms
  • Young
  • Breast Neoplasms
  • Denosumab
  • Breast Neoplasms
  • Neoplasms