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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Safety/Efficacy of Q-122 in Breast Cancer Patients Taking Tamoxifen or Aromatase Inhibitor
Scientific title
A Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Q-122 for the Treatment of Vasomotor Symptoms in Female Breast Cancer Patients/Survivors Taking Tamoxifen or an Aromatase Inhibitor
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vasomotor Symptoms (VMS) 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Treatment: Drugs - Q-122
Treatment: Drugs - Placebo

Experimental: Group 1, study drug - 65 patients treated with Q-122, 100 mg BID

Placebo Comparator: Group 2, placebo - 65 patients treated with placebo

Treatment: Drugs: Q-122
oral capsule of Q-122

Treatment: Drugs: Placebo
oral capsule of placebo

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Hot Flash Severity Score (HFSS) - The primary efficacy outcome measure will be the change from baseline in the HFSS for moderate and severe hot flashes (HFSS-m/s) calculated for each treatment week by multiplying the severity by the frequency using the following formula: (2 x number of moderate) + (3 x number of severe)
Timepoint [1] 0 0
4 weeks

Key inclusion criteria
1. Be a female, aged between 18 - 70 years on the day of informed consent.

2. Have a history of or current breast cancer and currently taking tamoxifen or an
aromatase inhibitor.

3. On a stable dose of TAM or an AI for a minimum of 30 days before the Screening Visit
and no anticipated need to change the dose for the duration of the study.

4. Experience an average of at least 50 moderate to severe hot flashes/week for the 2
weeks immediately preceding the Run-In Visit (i.e., during the Screening period).

5. If on thyroid medication, on a stable dose for a minimum of 30 days before the
Screening Visit and no anticipated need to change the dose for the duration of the

6. Willing and able to complete the daily participant diary, attend all study visits, and
participate in all study procedures.

7. Able to provide informed consent.
Minimum age
18 Years
Maximum age
70 Years
Can healthy volunteers participate?
Key exclusion criteria
1. Childbearing potential, pregnancy, or lactation except in patients who are on stable
dose of AI in combination with luteinizing hormone releasing hormone agonists such as
Zoladex, Leuprolide (Lupron) or equivalent. Non-childbearing potential is defined as
physiologically incapable of becoming pregnant by one of the following:

- Has had a partial or complete hysterectomy or

- Has had a bilateral oophorectomy or

- Has had a bilateral tubal ligation or fallopian tube inserts or

- Is post-menopausal (amenorrhea > 1 year) confirmed by levels of follicle
stimulating hormone (FSH). FSH levels may be lower in menopausal women treated
with tamoxifen when compared with FSH levels appropriate for confirming menopause
in women not treated with tamoxifen. For those patients who are on stable dose of
tamoxifen, confirmation of menopause is based on the clinical opinion of the PI
and medical monitor on a 'case-by-case basis'.

2. Currently experiencing undiagnosed vaginal bleeding.

3. Women with advanced breast cancer (Stage 4).

4. Greater than 60% reduction in the frequency of moderate to severe hot flashes during
the 1-week single blind Run-In period or inability to correctly record hot flashes
and/or drug dosing in the participant diary.

5. Participation in another clinical or surgical trial within 30 days prior to screening
or during the study without the prior written consent of the Medical Monitor.

6. Gastrointestinal, liver, kidney or other conditions which could interfere with the
absorption, distribution, metabolism or excretion of Q-122 at PI discretion.

7. Untreated overt hyperthyroidism.

8. Have any other medical condition, clinically important systemic disease or significant
co-morbidities or any finding during Screening that in the judgment of the
investigator puts the participant at increased risk by participation in this study, or
that may affect the reliability of participant diary entries.

9. Known inability to complete all study visits and study assessments for scheduling or
other reasons.

10. BMI > 40 kg/m2; Participants with a BMI greater than 40 kg/m2 may be enrolled on a
case-by-case basis if approved by the Medical Monitor and if the participant is not
deemed at increased risk of adverse effects based on body habitus and cardiovascular

11. Women with a history of, or current evidence of, abuse of alcohol or any drug
substance, or who regularly drink more than 3 standard drinks per day.

12. Uncontrolled systolic blood pressure =160 mmHg or diastolic blood pressure =95 mmHg on
3 consecutive readings within the screening visit.

13. Abnormal laboratory findings:

1. Hemoglobin < 9.5 g/dL (g/L); or any abnormal values that are deemed clinically
significant by the investigator should be discussed with the medical monitor
before being deemed ineligible.

2. Fasting ALT, AST, GGT, or bilirubin greater than twice the upper limit of normal
that is confirmed on a second sample.

3. <60 eGFR mL/min/1.73 m2.

14. In the opinion of the investigator, have substantial risk of disease progression
within the 3 months following screening and/or who potentially may require further
treatment for their breast cancer during the study period including follow-up.

15. Any other reason which in the investigator's opinion makes the participant unsuitable
for a clinical trial.

16. On any medications, either prescription or over-the-counter that are being taken
solely for the purpose of treating VMS including SSRI/SNRI, gabapentin or pregabalin.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people analysing the results/data
Intervention assignment
Other design features
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
ICON Group, Icon Cancer Care Wesley - Brisbane
Recruitment hospital [3] 0 0
School of Public Health and Preventive Medicine, Monash University - Melbourne
Recruitment hospital [4] 0 0
The Royal Women's Hospital - Melbourne
Recruitment hospital [5] 0 0
Keogh Institute for Medical Research - Perth
Recruitment hospital [6] 0 0
Women's Health Research Institute of Australia - Sydney
Recruitment hospital [7] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
4066 - Brisbane
Recruitment postcode(s) [3] 0 0
3004 - Melbourne
Recruitment postcode(s) [4] 0 0
3052 - Melbourne
Recruitment postcode(s) [5] 0 0
6009 - Perth
Recruitment postcode(s) [6] 0 0
2000 - Sydney
Recruitment postcode(s) [7] 0 0
2065 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Country [2] 0 0
United States of America
State/province [2] 0 0
Country [3] 0 0
United States of America
State/province [3] 0 0
Country [4] 0 0
United States of America
State/province [4] 0 0
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Country [7] 0 0
New Zealand
State/province [7] 0 0
Country [8] 0 0
New Zealand
State/province [8] 0 0
Country [9] 0 0
New Zealand
State/province [9] 0 0
Havelock North
Country [10] 0 0
New Zealand
State/province [10] 0 0

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Que Oncology
Other collaborator category [1] 0 0
Name [1] 0 0
Syneos Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
This is a Phase 2 proof-of-concept (POC) study designed to determine the effectiveness of
Q-122 for the treatment of Vasomotor Symptoms (VMS) versus placebo. Participants who meet all
eligibility criteria following the Screening/Run-In period will be randomized to 1 of 2
treatment arms; blinded Q-122 or placebo for a period of 28 days. All participants will be
followed for a 2-week, drug-free, follow-up period after their last dose of blinded
Q-122/placebo before termination from the study.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications