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Breast CancerPhase 3NCT02995772

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

A Phase 3 study testing Aromatase Inhibitors (Arimidex), Tamoxifen and SOB in people with Breast Cancer, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.

Completed

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

Official record
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Trial summary

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) Read more about this study

Who is it for?
Any age, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Aromatase Inhibitors (Arimidex), Tamoxifen and SOB
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteIndonesia
Study dates
Nov 2011to Nov 2018
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 Any age
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • IIIB/C and IV stage of breast cancer
  • received neoadjuvant hormonal therapy or neoadjuvant chemotherapy
  • had first and second biopsy (surgery) within 6 months

Who cannot join

  • had mastectomy before treatment
  • pregnant
  • disagree to enter the study
  • had been given hormonal therapy or chemotherapy before study
  • had contra-indication of SOB for pre-menopausal patients

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

  • Dharmais National Cancer Center Hospital

    Jakarta, 11420

Other trials in Indonesia

About this study

Official title: Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)

Read the detailed description

This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) between 2011 and 2016.

The primary end points are overall survival (OS) and progression free survival (PFS) with Kaplan Meier.

This study was approved by Ethical Committee in Dharmais National Cancer Hospital.

Conditions
Breast Cancer
Being tested
Aromatase Inhibitors (Arimidex), Tamoxifen, SOB, FAC, Aromatase Inhibitors (Femara)
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Aromatase Inhibitors (Arimidex)Drug

    Also called Anastrozole

    Comparison of efficacy with chemotherapy

  • TamoxifenDrug

    Also called Nolvadex, Soltamox

    Comparison of efficacy with chemotherapy

  • SOBProcedure or surgery

    Also called Salpingo-oophorectomy Bilateral

    Comparison of efficacy with chemotherapy

  • FACDrug

    Also called Fluorouracil, Adriamycin, Cytoxan

    Comparison of efficacy with hormonal therapy

  • Aromatase Inhibitors (Femara)Drug

    Also called Letrozole

    Comparison of efficacy with chemotherapy

  • Aromatase Inhibitors (Aromasin)Drug

    Also called Exemestane

    Comparison of efficacy with chemotherapy

Study groups in NCT02995772
Study groupRoleWhat they receive
Neoadjuvant hormonal therapyActive comparatorNeoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Receives: Drug: Aromatase Inhibitors (Arimidex); Drug: Tamoxifen; Procedure: SOB; Drug: Aromatase Inhibitors (Femara); Drug: Aromatase Inhibitors (Aromasin)
Neoadjuvant chemotherapyActive comparatorNeoadjuvant chemotherapy: FAC 6 cycles
Receives: Drug: FAC

What is being measured

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

  1. Overall survival

    length of time from the date of pathological diagnosis until death from any cause

    Measured: time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years

Secondary outcomes (1)

  1. Progressive free survival

    length of time from after treatment until tumor progression or death from any cause

    Measured: time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years

Timeline

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

  1. First posted16 Dec 2016 (estimated)
  2. Study startNov 2011
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
122 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02995772
Sponsor's protocol ID
049/PEP/08/2011
Status last verified
Jun 2019
First submitted
14 Dec 2016
Last updated
19 Jun 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided: We have not decided on this yet

Publications

  • Beatson GT. On the Treatment of Inoperable Cases of Carcinoma of the Mamma: Suggestions for a New Method of Treatment, with Illustrative Cases. Trans Med Chir Soc Edinb. 1896;15:153-179. No abstract available.

    PubMed 29584099

  • van de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967.

    PubMed 12490681

  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0.

    PubMed 15894097

  • Cardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, Pierga JY, Brain E, Causeret S, DeLorenzi M, Glas AM, Golfinopoulos V, Goulioti T, Knox S, Matos E, Meulemans B, Neijenhuis PA, Nitz U, Passalacqua R, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Sotiriou C, Stork L, Straehle C, Thomas G, Thompson AM, van der Hoeven JM, Vuylsteke P, Bernards R, Tryfonidis K, Rutgers E, Piccart M; MINDACT Investigators. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253.

    PubMed 27557300

  • Asad J, Jacobson AF, Estabrook A, Smith SR, Boolbol SK, Feldman SM, Osborne MP, Boachie-Adjei K, Twardzik W, Tartter PI. Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am J Surg. 2008 Oct;196(4):527-9. doi: 10.1016/j.amjsurg.2008.06.021.

    PubMed 18809056

  • Teshome M, Hunt KK. Neoadjuvant therapy in the treatment of breast cancer. Surg Oncol Clin N Am. 2014 Jul;23(3):505-23. doi: 10.1016/j.soc.2014.03.006. Epub 2014 Apr 24.

    PubMed 24882348

  • Mauriac L, MacGrogan G, Avril A, Durand M, Floquet A, Debled M, Dilhuydy JM, Bonichon F. Neoadjuvant chemotherapy for operable breast carcinoma larger than 3 cm: a unicentre randomized trial with a 124-month median follow-up. Institut Bergonie Bordeaux Groupe Sein (IBBGS). Ann Oncol. 1999 Jan;10(1):47-52. doi: 10.1023/a:1008337009350.

    PubMed 10076721

  • Chia YH, Ellis MJ, Ma CX. Neoadjuvant endocrine therapy in primary breast cancer: indications and use as a research tool. Br J Cancer. 2010 Sep 7;103(6):759-64. doi: 10.1038/sj.bjc.6605845. Epub 2010 Aug 10.

    PubMed 20700118

  • Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27.

    PubMed 26019189

  • Chuang E, Paul C, Flam A, McCarville K, Forst M, Shin S, Vahdat L, Swistel A, Simmons R, Osborne M. Breast cancer subtypes in Asian-Americans differ according to Asian ethnic group. J Immigr Minor Health. 2012 Oct;14(5):754-8. doi: 10.1007/s10903-012-9577-7.

    PubMed 22286607

  • Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010 Jul;134(7):e48-72. doi: 10.5858/134.7.e48.

    PubMed 20586616

  • Marcus DM, Switchenko JM, Prabhu R, O'Regan R, Zelnak A, Fasola C, Mister D, Torres MA. Neoadjuvant Hormonal Therapy is Associated with Comparable Outcomes to Neoadjuvant Chemotherapy in Post-Menopausal Women with Estrogen Receptor-Positive Breast Cancer. Front Oncol. 2013 Dec 27;3:317. doi: 10.3389/fonc.2013.00317. eCollection 2013.

    PubMed 24409418

  • Semiglazov VF, Semiglazov VV, Dashyan GA, Ziltsova EK, Ivanov VG, Bozhok AA, Melnikova OA, Paltuev RM, Kletzel A, Berstein LM. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer. Cancer. 2007 Jul 15;110(2):244-54. doi: 10.1002/cncr.22789.

    PubMed 17538978

  • Preece PE, Wood RA, Mackie CR, Cuschieri A. Tamoxifen as initial sole treatment of localised breast cancer in elderly women: a pilot study. Br Med J (Clin Res Ed). 1982 Mar 20;284(6319):869-70. doi: 10.1136/bmj.284.6319.869-a. No abstract available.

    PubMed 6802332

  • Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235.

    PubMed 18258986

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aromatase Inhibitors (Arimidex), Tamoxifen and SOB in people with Breast Cancer, run by Dharmais National Cancer Center Hospital at 1 site in Indonesia.

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 3 inclusion and 5 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 19 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. 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. 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?

Overall survival (time frame: time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years). 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 NCT02995772, which also lists 24 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 19 Jun 2019.

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