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A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.


Phase 3
45 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase 3 Study to Determine the Treatment Effect of Denosumab in Subjects With Non-Metastatic Breast Cancer Receiving Aromatase Inhibitor Therapy.


Inclusion Criteria:



- Histologically or cytologically confirmed adenocarcinoma of the breast;

- Female subjects with non-metastatic disease who are estrogen receptor (ER) and/or
progesterone receptor (PR) positive, and who have completed their treatment pathway;

- Subjects who are currently on, or will initiate an approved non-steroidal aromatase
inhibitor therapy (eg, anastrazole) in the adjuvant setting;

- Postmenopausal woman, defined as a woman fulfilling any one of the following
criteria:

- Having undergone a bilateral oophorectomy;

- Age ≥ 60 years;

- Aged < 60 years meeting the following requirements:

- FSH and estradiol in the postmenopausal range;

- A negative pregnancy test within 7 days prior to randomization. Subjects who have
undergone a hysterectomy do not require a pregnancy test.

- More criteria may apply.

Exclusion Criteria:

- Aromatase inhibitor therapy for more than 24 months;

- Prior or concurrent treatment with Selective Estrogen Receptor Modulators (eg,
tamoxifen);

- Evidence of metastatic disease;

- Current or prior IV bisphosphonate administration;

- Oral bisphosphonate treatment greater than or equal to 3 years continuously OR
greater than 3 months but less than 3 years unless there was a washout period of at
least 1 year prior to randomization OR any use during the 3-month period prior to
randomization;

- Prior administration of denosumab;

- Known liver or renal deficiency;

- Recurrence of the primary malignancy (eg, during the allowed interval of pretreatment
with aromatase inhibitor);

- Diagnosis of any second non-breast malignancy within the last 5 years, except for
adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma
of the cervix uteri;

- Any kind of disorder that compromises the ability to give written informed consent
and/or comply with study procedures;

- More criteria may apply.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

The time to the first clinical fracture.

Safety Issue:

No

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

Austria: AGES - PharmaMed Austria Institut Wissenschaft & Information

Study ID:

20050209

NCT ID:

NCT00556374

Start Date:

December 2006

Completion Date:

January 2022

Related Keywords:

  • Breast Cancer
  • confirmed adenocarcinoma
  • non-metastatic breast cancer
  • estrogen receptor positive
  • progesterone receptor positive
  • non-steroidal aromatase
  • aromatase inhibitor therapy
  • postmenopausal woman
  • adjuvant chemotherapy
  • neoadjuvant chemotherapy
  • Breast Neoplasms

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