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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02995772
• Other study ID #: 049/PEP/08/2011
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: November 2018

Study information

• Verified date: June 2019
• Source: Dharmais National Cancer Center Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• IIIB/C and IV stage of breast cancer

• received neoadjuvant hormonal therapy or neoadjuvant chemotherapy

• had first and second biopsy (surgery) within 6 months

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Aromatase Inhibitors (Arimidex)
Comparison of efficacy with chemotherapy
• Tamoxifen
Comparison of efficacy with chemotherapy

Procedure:
• SOB
Comparison of efficacy with chemotherapy

Drug:
• FAC
Comparison of efficacy with hormonal therapy
• Aromatase Inhibitors (Femara)
Comparison of efficacy with chemotherapy
• Aromatase Inhibitors (Aromasin)
Comparison of efficacy with chemotherapy

Locations

Country	Name	City	State
Indonesia	Dharmais National Cancer Center Hospital	Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dharmais National Cancer Center Hospital

Country where clinical trial is conducted

Indonesia, 

References & Publications (24)

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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. Review. — View Citation

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. — View Citation

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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. — View Citation

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Robertson JF, Todd JH, Ellis IO, Elston CW, Blamey RW. Comparison of mastectomy with tamoxifen for treating elderly patients with operable breast cancer. BMJ. 1988 Aug 20-27;297(6647):511-4. — View Citation

Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010 Apr 10;28(11):1958-62. doi: 10.1200/JCO.2009.25.5414. Epub 2010 Mar 1. Review. — View Citation

Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortés J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemother — View Citation

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-posi — View Citation

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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. Review. — View Citation

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-e — View Citation

von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kümmel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy fo — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival	length of time from the date of pathological diagnosis until death from any cause	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	Progressive free survival	length of time from after treatment until tumor progression or death from any cause	time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years