Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast Cancer

NCT05334459 | Recruiting

• 1 other identifier: ISTMET-BHWGI2022-1
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Locoregional (LRT) of the primary tumor in de-novo metastatic breast cancer (dnMBC) is no longer only a surgical challenge, but more the final decision of a multidisciplinary tumor board including medical oncologists, radiation oncologists and surgical oncologists. It is no longer only a question of locoregional control but rather a wider issue of improving overall survival (OS), due to the possible biological link between primary tumor and metastases. A multimodal approach, including LRT with curative intent should be considered for selected dnMBC patients, especially for the subset of bone-only metastatic ones.

Conditions

Metastatic Breast Cancer

Keywords

breast cancer, metastasis, radiotherapy, primer surgery

Outcome Measures

Primary Outcomes (1)

• Survival

  Phase I study to evaluate feasibility (overall and diseas free survival) of this curative intent treatment approach to patients presenting with dnMBC with oligometastatic disease.

  5 years follow-up

Study Arms (1)

Intervention

Operable, postmenopausal ER/PR positive and Her2 neu (-), oligometastatic dnMBC patients * Primary tumor biopsy, Metastatic site biopsy (Bone, liver, etc) o ER / PR /Her2 /Ki67 study * Collection of CTC. * Radiotherapy (RT) to the primary breast tumor (Hypo fractionated) * All patients will receive the standard of care treatment with CDK4/6 inhibitor + AI for 6 months (at least 26 weeks). o Denosumab, Biphosphonate for bone metastasis * RT to metastatic side (if visible). Continue Systemic therapy * 12 months, patients will have LRT surgery (BCS/mastectomy + LN evaluation; SLNB+ALND) + RT (based on the institutional practice). Collect CTC and ER/PR/Her 2 in the final specimen * ST will be continued until progression and/or unmanageable toxicity. * Radiologic evaluation every 3-6-month based on institutional practice.

Radiation: radiotherapy

Interventions

radiotherapy RADIATION

Oligometastatic disease (defined here as 5 or fewer sites of metastatic disease involving 3 or fewer organ systems) * Primary tumor biopsy, Metastatic site biopsy (Bone, liver, etc) (if there is, based on institutional practice) o ER / PR /Her2 /Ki67 study) * Collection of CTC. * Radiotherapy (RT) to the primary breast tumor (Hypo fractionated) * All patients will receive the standard of care treatment with CDK4/6 inhibitor + AI for 6 months (at least 26 weeks). o Denosumab, Biphosphonate for bone metastasis * RT to metastatic side (if visible). Continue Systemic therapy * 12 months, patients will have LRT surgery (BCS/mastectomy + LN evaluation; SLNB+ALND) + RT (based on the institutional practice). Collect CTC and ER/PR/Her 2 in the final specimen * ST will be continued until progression and/or unmanageable toxicity. * Radiologic evaluation every 3-6-month based on institutional practice.

Intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Operable, postmenopausal ER/PR positive and Her2 neu (-), oligometastatic dnMBC patients.

You may qualify if:

• Primary breast tumor amenable for complete surgical resection, patients in good physical condition for receiving protocol driven locoregional and systemic treatments and receiving radiotherapy.

You may not qualify if:

• Primary tumor not amenable for complete resection; primary tumor with extended infection, bleeding, or necrosis; patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment; synchronous primary cancer at the contralateral breast; clinically involved contralateral axillary nodes; patients not suitable for adequate follow-up, and failure to give informed consent. Pregnancy and lactation.

Sponsors & Collaborators

• Ankara Oncology Research and Training Hospital: lead

Study Sites (1)

Lutfi Dogan

Ankara, Turkey (Türkiye)

RECRUITING

Related Publications (8)

• Soran A, Ozmen V, Ozbas S, Karanlik H, Muslumanoglu M, Igci A, Canturk NZ, Utkan Z, Evrensel T, Sezgin E; MF07-01 Study Group. Primary Surgery with Systemic Therapy in Patients with de Novo Stage IV Breast Cancer: 10-year Follow-up; Protocol MF07-01 Randomized Clinical Trial. J Am Coll Surg. 2021 Dec;233(6):742-751.e5. doi: 10.1016/j.jamcollsurg.2021.08.686. Epub 2021 Sep 13.

  PMID: 34530124 BACKGROUND

• Lee SJ, Park S, Ahn HK, Yi JH, Cho EY, Sun JM, Lee JE, Nam SJ, Yang JH, Park YH, Ahn JS, Im YH. Implications of bone-only metastases in breast cancer: favorable preference with excellent outcomes of hormone receptor positive breast cancer. Cancer Res Treat. 2011 Jun;43(2):89-95. doi: 10.4143/crt.2011.43.2.89. Epub 2011 Jun 30.

  PMID: 21811424 BACKGROUND

• Sledge GW Jr, Toi M, Neven P, Sohn J, Inoue K, Pivot X, Burdaeva O, Okera M, Masuda N, Kaufman PA, Koh H, Grischke EM, Conte P, Lu Y, Barriga S, Hurt K, Frenzel M, Johnston S, Llombart-Cussac A. The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial. JAMA Oncol. 2020 Jan 1;6(1):116-124. doi: 10.1001/jamaoncol.2019.4782.

  PMID: 31563959 BACKGROUND

• Onderdonk BE, Gutiontov SI, Chmura SJ. The Evolution (and Future) of Stereotactic Body Radiotherapy in the Treatment of Oligometastatic Disease. Hematol Oncol Clin North Am. 2020 Feb;34(1):307-320. doi: 10.1016/j.hoc.2019.09.003. Epub 2019 Oct 28.

  PMID: 31739951 BACKGROUND

• Wang K, Shi Y, Li ZY, Xiao YL, Li J, Zhang X, Li HY. Metastatic pattern discriminates survival benefit of primary surgery for de novo stage IV breast cancer: A real-world observational study. Eur J Surg Oncol. 2019 Aug;45(8):1364-1372. doi: 10.1016/j.ejso.2019.02.013. Epub 2019 Feb 19.

  PMID: 30837102 BACKGROUND

• Trovo M, Furlan C, Polesel J, Fiorica F, Arcangeli S, Giaj-Levra N, Alongi F, Del Conte A, Militello L, Muraro E, Martorelli D, Spazzapan S, Berretta M. Radical radiation therapy for oligometastatic breast cancer: Results of a prospective phase II trial. Radiother Oncol. 2018 Jan;126(1):177-180. doi: 10.1016/j.radonc.2017.08.032. Epub 2017 Sep 21.

  PMID: 28943046 BACKGROUND

• Milano MT, Katz AW, Zhang H, Huggins CF, Aujla KS, Okunieff P. Oligometastatic breast cancer treated with hypofractionated stereotactic radiotherapy: Some patients survive longer than a decade. Radiother Oncol. 2019 Feb;131:45-51. doi: 10.1016/j.radonc.2018.11.022. Epub 2018 Dec 28.

  PMID: 30773186 BACKGROUND

• Soran A, Dogan L, Isik A, Ozbas S, Trabulus DC, Demirci U, Karanlik H, Soyder A, Dag A, Bilici A, Dogan M, Koksal H, Sendur MAN, Gulcelik MA, Maralcan G, Cabioglu N, Yeniay L, Utkan Z, Simsek T, Karadurmus N, Daglar G, Yildiz B, Uras C, Tukenmez M, Yildirim A, Kutun S, Ozaslan C, Karaman N, Akcay MN, Toktas O, Sezgin E. The Effect of Primary Surgery in Patients with De Novo Stage IV Breast Cancer with Bone Metastasis Only (Protocol BOMET MF 14-01): A Multi-Center, Prospective Registry Study. Ann Surg Oncol. 2021 Sep;28(9):5048-5057. doi: 10.1245/s10434-021-09621-8. Epub 2021 Feb 2.

  PMID: 33532878 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Neoplasm Metastasis

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Serdar Ozbas, Prof

  Endocrine and Breast Surgeon-Ankara

  PRINCIPAL INVESTIGATOR

• Atilla Soran, Prof

  Magee-Womens Hospital,University of Pittsburgh Medical Center

  STUDY CHAIR

Central Study Contacts

Lutfi Dogan, Prof

CONTACT

+905057134549; lutfidogan1@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 19, 2022
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion (Estimated): March 31, 2028
• Last Updated: April 26, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)