Breast CancerPhase 3HBCNCT01246427

Evaluation of Homeopathic Treatment for Hot Flashes in Non Metastatic Breast Cancer

A Phase 3 study testing BRN01 in people with Breast Cancer, run by Centre Leon Berard at 9 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: BRN01
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 138 participants
Where: 9 sitesFrance
Study dates: Jan 2010to Nov 2014
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female patient aged ≥ 18 years
Women with histologically proven non metastatic breast cancer
ECOG PS ≤ 1
Patient receiving adjuvant hormonal therapy for at least 1 month (aromatase inhibitor or Tamoxifen ± ovarian function suppression (Luteinizing Hormone Releasing Hormone agonist (LH-RH agonist), ovariectomy...))
Patient complaining of hot flashes with moderate to severe intensity, affecting quality of life, for at least 1 month before inclusion
Patient agreement not to start another hot flash treatment during the study (allopathic treatment, E vitamin, dietary supplement, phytotherapy, acupuncture...)

Show all 9Show fewer

Patient able to understand, read and write French
Mandatory affiliation with a health insurance system
Signed, written informed consent

Who cannot join

Ongoing chemotherapy or radiotherapy, or treatment planned to begin during the study
Patient with a condition known to induce hot flashes such as hyperthyroidism, diabetes, adrenal tumor, enteric carcinoid tumor, mastocytosis...
Patient with severe renal failure, severe hepatic failure, or cardiovascular disease
Patient with one of the following contraindications:
known hypersensitivity to one of the components of the study drug
galactose, fructose intolerance

Show all 11Show fewer

Lapp lactase deficiency, isomaltase invertase deficiency
Glucose or galactose malabsorption syndrome
Follow up impossible because of social, familial, geographical or psychological reasons
Patient suspected of poor compliance with protocol or treatment
Participation in another biomedical research trial in the same indication, or administration of an experimental drug in the same indication in the 30 days before inclusion

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

France9 sites

Centre Hospitalier de Chambery
Chambéry
Centre Jean Perrin
Clermont-Ferrand
Centre Leon Berard
Lyon, 69373
Centre Hospitalier de Montelimar
Montélimar
Centre Hospitalier d'Annecy
Pringy
Centre Hospitalier de Roanne
Roanne
Clinique Armoricaine de radiologie
Saint-Brieuc
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez
Centre Hospitalier de Valence
Valence

Other trials in France

About this study

Official title: Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy

The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.

Read the detailed description

Chemotherapy is used as an adjuvant treatment for breast cancer, like hormone therapy in patients with hormone-sensitive breast cancer or immunotherapy in those with Human Epidermal growth factor Receptor 2 (HER2)-overexpressing cancer.

These adjuvant treatments reduce the risk of recurrence and metastasis. The side effects of hormone therapy are known and depend on the therapeutic strategy and the drugs used. The side effects of Tamoxifen are similar to menopausal symptoms: hot flashes (half of the female population), vaginal dryness or leukorrhea, nausea, irregular menstruation, benign ovarian cyst and, less frequently, weight gain. Aromatase inhibitors have the same side effects, though with lesser frequency and intensity. The incidence rate of hot flashes after adjuvant treatment in menopausal women with localized breast cancer is 60 to 65 %, and these reactions are very severe in one third of these women. Despite this fact, the management of hot flashes is not systematic and there is currently no therapeutic strategy with proven efficiency. BRN01 (Boiron laboratory) is a homeopathic remedy whose active ingredient is already present in other homeopathic drugs indicated for the management of menopausal hot flashes. BRN01 could reduce the intensity of the reaction in women with breast cancer receiving adjuvant hormonal treatment.

Conditions: Breast Cancer
Being tested: BRN01, Placebo
Keywords: Adjuvant hormonal therapy, Homeopathic treatment, Hot flashes, Quality of life, Hot flash score
Medical subject headings: Breast Neoplasms, Hot Flashes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BRN01Drug
2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
PlaceboDrug
2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).

Study groups in NCT01246427
Study group	Role	What they receive
BRN01	Experimental	A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms: * Experimental: BRN01 * Placebo Comparator: Placebo Receives: Drug: BRN01
Placebo	Placebo comparator	A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms: * Experimental: BRN01 * Placebo Comparator: Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
The hot flash score is equal to: (number of hot flashes/day) x (mean intensity/day).
Treatment efficiency scores will be calculated as follows: (hot flash score on the 4th week of the second period)-(hot flash score on the 2nd week of the first period).
Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).
Measured: The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 4th week of the second period (placebo or BRN01).

Secondary outcomes (7)

Evaluation of BRN01 efficacy in reducing the hot flash score after 8 weeks of treatment
Treatment efficacy scores will be calculated as follows: (hot flash score on the 8th week of the second period)-(hot flash score on the 2nd week of the first period).
Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).
Measured: The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 8th week of the second period (placebo or BRN01).
Evaluation of the mean daily intensity of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.
Measured: The patients are instructed to record the intensity of hot flashes in a self-evaluation booklet, daily, during the 2nd week of the first period (run-in period), and during the 4th and 8th weeks of the second period (placebo or BRN01).
Evaluation of the mean daily frequency of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.
Measured: The patients are instructed to record the number of hot flashes in a self-evaluation booklet, daily, during the 2nd week of the first period (run-in period), and during the 4th and 8th weeks of the second period (placebo or BRN01).
Evaluation of quality of life in both arms
Measured: The patients are instructed to complete quality of life items on the 7th day of each evaluation period (2nd week of the run-in period, 4th and 8th weeks of the second period)
Evaluation of patient satisfaction with the treatment and with the management of hot flashes.
Measured: The patients are instructed to record all new hot flash treatments started, as well as their satisfaction with their management, on the 7th day of each evaluation period (2nd week of the run-in period, 4th and 8th weeks of the second period).
Evaluation of treatment tolerance
Measured: Side effects are registered by the oncologist at each visit (planned during the 3rd week or the 4th week of the run-in period and during the 9th week or the 10th week of the second period)
Evaluation of patient compliance
Measured: The number of remaining tablets will be counted at each visit (planned during the 3rd week or the 4th week of the run-in period and during the 9th week or the 10th week of the second period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Nov 2014

First posted23 Nov 2010 (estimated)
Study startJan 2010
Primary completionMay 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (26)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Centre Leon BerardThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 138 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01246427
Sponsor's protocol ID: HBC
Other IDs: ET2008-048
Acronym: HBC
Status last verified: Sep 2016
First submitted: 16 Nov 2010
Last updated: 14 Sep 2016
Results posted: No
Data monitoring committee: No

Publications

Remontet L, Esteve J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Mace-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.
PubMed 12684578
Menegoz F, Black RJ, Arveux P, Magne V, Ferlay J, Buemi A, Carli PM, Chapelain G, Faivre J, Gignoux M, Grosclaude P, Mace-Lesec'h J, Raverdy N, Schaffer P. Cancer incidence and mortality in France in 1975-95. Eur J Cancer Prev. 1997 Oct;6(5):442-66. doi: 10.1097/00008469-199710000-00005.
PubMed 9466116
Coleman MP. Trends in breast cancer incidence, survival, and mortality. Lancet. 2000 Aug 12;356(9229):590-1; author reply 593. doi: 10.1016/S0140-6736(00)02593-9. No abstract available.
PubMed 10950250
Breast International Group (BIG) 1-98 Collaborative Group; Thurlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005 Dec 29;353(26):2747-57. doi: 10.1056/NEJMoa052258.
PubMed 16382061
Finck G, Barton DL, Loprinzi CL, Quella SK, Sloan JA. Definitions of hot flashes in breast cancer survivors. J Pain Symptom Manage. 1998 Nov;16(5):327-33. doi: 10.1016/s0885-3924(98)00090-6.
PubMed 9846028
Stearns V, Ullmer L, Lopez JF, Smith Y, Isaacs C, Hayes D. Hot flushes. Lancet. 2002 Dec 7;360(9348):1851-61. doi: 10.1016/s0140-6736(02)11774-0.
PubMed 12480376
Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737.
PubMed 7595732
Fellowes D, Fallowfield LJ, Saunders CM, Houghton J. Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for 'well-tolerated' treatments? Breast Cancer Res Treat. 2001 Mar;66(1):73-81. doi: 10.1023/a:1010684903199.
PubMed 11368413
Lower EE, Blau R, Gazder P, Tummala R. The risk of premature menopause induced by chemotherapy for early breast cancer. J Womens Health Gend Based Med. 1999 Sep;8(7):949-54. doi: 10.1089/jwh.1.1999.8.949.
PubMed 10534297
McPhail G, Smith LN. Acute menopause symptoms during adjuvant systemic treatment for breast cancer: a case-control study. Cancer Nurs. 2000 Dec;23(6):430-43. doi: 10.1097/00002820-200012000-00005.
PubMed 11128122
Loprinzi CL, Zahasky KM, Sloan JA, Novotny PJ, Quella SK. Tamoxifen-induced hot flashes. Clin Breast Cancer. 2000 Apr;1(1):52-6. doi: 10.3816/cbc.2000.n.004.
PubMed 11899390
Love RR, Cameron L, Connell BL, Leventhal H. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991 Sep;151(9):1842-7.
PubMed 1888251
Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-43. doi: 10.1016/s0140-6736(97)02293-9.
PubMed 9310601
Jonas WB, Kaptchuk TJ, Linde K. A critical overview of homeopathy. Ann Intern Med. 2003 Mar 4;138(5):393-9. doi: 10.7326/0003-4819-138-5-200303040-00009.
PubMed 12614092
Cucherat M, Haugh MC, Gooch M, Boissel JP. Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33. doi: 10.1007/s002280050716.
PubMed 10853874

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placebo-controlled Evaluation of the Homeopathic Drug BRN01 for the Treatment of Hot Flashes in Women With Non Metastatic Breast Cancer Treated by Adjuvant Hormonal Therapy
ClinicalTrials.gov ID: NCT01246427
Acronym / sponsor ID: HBC / HBC
Conditions: Breast Cancer
Keywords: Adjuvant hormonal therapy, Homeopathic treatment, Hot flashes, Quality of life, Hot flash score
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 138 participants (actual)
Lead sponsor: Centre Leon BerardUniversity, hospital or other
Collaborators: BOIRON
Study start: Jan 2010
Primary completion: May 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 23 Nov 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy of a homeopathic treatment (BRN01) in reducing hot flash scores after 4 weeks of treatment.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BRN01	Experimental	Drug: BRN01A 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms: * Experimental: BRN01 * Placebo Comparator: Placebo
Placebo	Placebo comparator	Drug: PlaceboA 2 to 4 weeks run-in period is planned, during which all patients receive single blinded "hot flash evaluation treatment" which is actually a placebo (2 tablets every morning and every evening during 2 to 4 weeks). At the end of this period, the hot flash score is calculated. If the score is ≥10, the patient can be randomized to one of the 2 arms: * Experimental: BRN01 * Placebo Comparator: Placebo

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Female patient aged ≥ 18 years
Women with histologically proven non metastatic breast cancer
ECOG PS ≤ 1
Patient receiving adjuvant hormonal therapy for at least 1 month (aromatase inhibitor or Tamoxifen ± ovarian function suppression (Luteinizing Hormone Releasing Hormone agonist (LH-RH agonist), ovariectomy...))
Patient complaining of hot flashes with moderate to severe intensity, affecting quality of life, for at least 1 month before inclusion

Key exclusion criteria (11 listed)

Ongoing chemotherapy or radiotherapy, or treatment planned to begin during the study
Patient with a condition known to induce hot flashes such as hyperthyroidism, diabetes, adrenal tumor, enteric carcinoid tumor, mastocytosis...
Patient with severe renal failure, severe hepatic failure, or cardiovascular disease
Patient with one of the following contraindications:
Follow up impossible because of social, familial, geographical or psychological reasons

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BRN012 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).	Drug	BRN01
Placebo2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).	Drug	Placebo

Primary outcome

Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment
Time frame: The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 4th week of the second period (placebo or BRN01).
The hot flash score is equal to: (number of hot flashes/day) x (mean intensity/day). Treatment efficiency scores will be calculated as follows: (hot flash score on the 4th week of the second period)-(hot flash score on the 2nd week of the first period). Then efficiency scores will be compared between the 2 arms (placebo versus BRN01).

7 secondary outcomes

Evaluation of BRN01 efficacy in reducing the hot flash score after 8 weeks of treatment
Time frame: The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 8th week of the second period (placebo or BRN01).
Evaluation of the mean daily intensity of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.
Time frame: The patients are instructed to record the intensity of hot flashes in a self-evaluation booklet, daily, during the 2nd week of the first period (run-in period), and during the 4th and 8th weeks of the second period (placebo or BRN01).
Evaluation of the mean daily frequency of hot flashes during the run-in period and on the 4th and 8th weeks of treatment in both arms.
Time frame: The patients are instructed to record the number of hot flashes in a self-evaluation booklet, daily, during the 2nd week of the first period (run-in period), and during the 4th and 8th weeks of the second period (placebo or BRN01).
Evaluation of quality of life in both arms
Time frame: The patients are instructed to complete quality of life items on the 7th day of each evaluation period (2nd week of the run-in period, 4th and 8th weeks of the second period)
Evaluation of patient satisfaction with the treatment and with the management of hot flashes.
Time frame: The patients are instructed to record all new hot flash treatments started, as well as their satisfaction with their management, on the 7th day of each evaluation period (2nd week of the run-in period, 4th and 8th weeks of the second period).
Evaluation of treatment tolerance
Time frame: Side effects are registered by the oncologist at each visit (planned during the 3rd week or the 4th week of the run-in period and during the 9th week or the 10th week of the second period)
Evaluation of patient compliance
Time frame: The number of remaining tablets will be counted at each visit (planned during the 3rd week or the 4th week of the run-in period and during the 9th week or the 10th week of the second period)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
Background: PubMed 12684578Remontet L, Esteve J, Bouvier AM, Grosclaude P, Launoy G, Menegoz F, Exbrayat C, Tretare B, Carli PM, Guizard AV, Troussard X, Bercelli P, Colonna M, Halna JM, Hedelin G, Mace-Lesec'h J, Peng J, Buemi A, Velten M, Jougla E, Arveux P, Le Bodic L, Michel E, Sauvage M, Schvartz C, Faivre J. Cancer incidence and mortality in France over the period 1978-2000. Rev Epidemiol Sante Publique. 2003 Feb;51(1 Pt 1):3-30.
Background: PubMed 9466116Menegoz F, Black RJ, Arveux P, Magne V, Ferlay J, Buemi A, Carli PM, Chapelain G, Faivre J, Gignoux M, Grosclaude P, Mace-Lesec'h J, Raverdy N, Schaffer P. Cancer incidence and mortality in France in 1975-95. Eur J Cancer Prev. 1997 Oct;6(5):442-66. doi: 10.1097/00008469-199710000-00005.
Background: PubMed 10950250Coleman MP. Trends in breast cancer incidence, survival, and mortality. Lancet. 2000 Aug 12;356(9229):590-1; author reply 593. doi: 10.1016/S0140-6736(00)02593-9. No abstract available.
Background: PubMed 16382061Breast International Group (BIG) 1-98 Collaborative Group; Thurlimann B, Keshaviah A, Coates AS, Mouridsen H, Mauriac L, Forbes JF, Paridaens R, Castiglione-Gertsch M, Gelber RD, Rabaglio M, Smith I, Wardley A, Price KN, Goldhirsch A. A comparison of letrozole and tamoxifen in postmenopausal women with early breast cancer. N Engl J Med. 2005 Dec 29;353(26):2747-57. doi: 10.1056/NEJMoa052258.
Background: PubMed 9846028Finck G, Barton DL, Loprinzi CL, Quella SK, Sloan JA. Definitions of hot flashes in breast cancer survivors. J Pain Symptom Manage. 1998 Nov;16(5):327-33. doi: 10.1016/s0885-3924(98)00090-6.
Background: PubMed 12480376Stearns V, Ullmer L, Lopez JF, Smith Y, Isaacs C, Hayes D. Hot flushes. Lancet. 2002 Dec 7;360(9348):1851-61. doi: 10.1016/s0140-6736(02)11774-0.
Background: PubMed 7595732Couzi RJ, Helzlsouer KJ, Fetting JH. Prevalence of menopausal symptoms among women with a history of breast cancer and attitudes toward estrogen replacement therapy. J Clin Oncol. 1995 Nov;13(11):2737-44. doi: 10.1200/JCO.1995.13.11.2737.
Background: PubMed 11368413Fellowes D, Fallowfield LJ, Saunders CM, Houghton J. Tolerability of hormone therapies for breast cancer: how informative are documented symptom profiles in medical notes for 'well-tolerated' treatments? Breast Cancer Res Treat. 2001 Mar;66(1):73-81. doi: 10.1023/a:1010684903199.
Background: PubMed 10534297Lower EE, Blau R, Gazder P, Tummala R. The risk of premature menopause induced by chemotherapy for early breast cancer. J Womens Health Gend Based Med. 1999 Sep;8(7):949-54. doi: 10.1089/jwh.1.1999.8.949.
Background: PubMed 11128122McPhail G, Smith LN. Acute menopause symptoms during adjuvant systemic treatment for breast cancer: a case-control study. Cancer Nurs. 2000 Dec;23(6):430-43. doi: 10.1097/00002820-200012000-00005.
Background: PubMed 11899390Loprinzi CL, Zahasky KM, Sloan JA, Novotny PJ, Quella SK. Tamoxifen-induced hot flashes. Clin Breast Cancer. 2000 Apr;1(1):52-6. doi: 10.3816/cbc.2000.n.004.
Background: PubMed 1888251Love RR, Cameron L, Connell BL, Leventhal H. Symptoms associated with tamoxifen treatment in postmenopausal women. Arch Intern Med. 1991 Sep;151(9):1842-7.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pierre Etienne Heudel, MD principal investigator

Centre Leon Berard, France

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BRN01 in people with Breast Cancer, run by Centre Leon Berard at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of BRN01 efficacy in reducing hot flash score after 4 weeks of treatment (time frame: The patients are instructed to record the number and intensity of hot flashes in a self-evaluation booklet every day during the 2nd week of the first period (run-in period) and during the 4th week of the second period (placebo or BRN01).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01246427, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.