Metastatic Breast CancerSTAR-BNCT06489821
STereotactic Body Radiotherapy (SBRT) for Oligoprogressive Breast Cancer
A study testing Stereotactic body radiotherapy in people with Metastatic Breast Cancer and Oligoprogression, run by Juravinski Cancer Center.
Trial summary
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Oligoprogression
- What is being tested?
- Stereotactic body radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+/Her2-) on endocrine therapy + CDK4/6 inhibitor or Her-2 positive (hormone receptor positive or negative /Her2+) on Her2-targeted therapy regimens.
- Progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.
- Patients must have previously controlled disease for at least six months on current systemic therapy
- Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions
Who cannot join
- Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
- Progression on 2nd line or subsequent lines of therapy
- Lacks CT or bone scan Imaging within previous 45 days;
- Progression in >3 sites in the liver or lung;
- Hormone positive disease on endocrine therapy only at time of enrollment;
- Previous radiotherapy to same site or vicinity preventing definitive SBRT (e.g. within 5 cm);
Show all 10Show fewer
- Lesions deemed not amenable to SBRT due to large size or location;
- Unacceptable fracture risk according to clinician judgement for bone lesions;
- Brain metastasis or Spinal cord compression;
- History of major radiosensitivity syndrome or contraindications to radiotherapy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Kyle McGowan contact
About this study
Official title: STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.
- Conditions
- Metastatic Breast Cancer, Oligoprogression
- Being tested
- Stereotactic body radiotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Stereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy
| Study group | Role | What they receive |
|---|---|---|
| Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapy | Experimental | SBRT in 5 or 2 (or 4) fractions for body and spine respectively over 2 weeks, while continuing first line systemic therapy Receives: Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with change in systemic therapy
Change in systemic therapy will occur with progression with the following criteria:
- Progression not amenable to further SBRT, including multifocal (>3) sites;
- Progression in lesion not amenable to further SBRT;
- Rapid progression such that treating medical oncologist believes change in therapy is warranted;
- Progression in location including, including visceral metastasis, such that treating medical oncologist believes change in therapy is warranted
Measured: Six months
Secondary outcomes (5)
Progression-free survival
Progression outside radiotherapy field per RECIST 1.1
Measured: 3, 6, 12, 18, and 24 months
Local progression
Progression within a treated lesion per RECIST 1.1
Measured: 3, 6, 12, 18, and 24 months
Time to chemotherapy
Initiation of cytotoxic therapy
Measured: 3, 6, 12, 18, and 24 months
Overall Survival
Proportion of patients alive
Measured: 3, 6, 12, 18, and 24 months
CTCAE Toxicity
common terminology criteria for adverse events 5.0
Measured: 3, 6, 12, 18, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juravinski Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Responsible party
- Principal investigator, Elysia Donovan, Juravinski Cancer Center
- Investigators
- Kyle McGowan, Study director, Juravinski CC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489821
- Sponsor's protocol ID
- STAR-B
- Acronym
- STAR-B
- Status last verified
- Jul 2024
- First submitted
- 16 Nov 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.
PubMed 25524798Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
PubMed 27959613Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.
PubMed 26947331Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, Andre F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. doi: 10.1056/NEJMoa1609709. Epub 2016 Oct 7.
PubMed 27717303Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155.
PubMed 29718092Swain SM, Miles D, Kim SB, Im YH, Im SA, Semiglazov V, Ciruelos E, Schneeweiss A, Loi S, Monturus E, Clark E, Knott A, Restuccia E, Benyunes MC, Cortes J; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Apr;21(4):519-530. doi: 10.1016/S1470-2045(19)30863-0. Epub 2020 Mar 12.
PubMed 32171426Andre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.
PubMed 31091374Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S, Lindemann JP, Sapunar F, Martin M. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2010 Oct 20;28(30):4594-600. doi: 10.1200/JCO.2010.28.8415. Epub 2010 Sep 20.
PubMed 20855825Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7.
PubMed 29223745Sammons S, Kornblum NS, Blackwell KL. Fulvestrant-Based Combination Therapy for Second-Line Treatment of Hormone Receptor-Positive Advanced Breast Cancer. Target Oncol. 2019 Feb;14(1):1-12. doi: 10.1007/s11523-018-0587-9.
PubMed 30136059Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Muller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):597-609. doi: 10.1056/NEJMoa1914609. Epub 2019 Dec 11.
PubMed 31825569Bredin P, Walshe JM, Denduluri N. Systemic therapy for metastatic HER2-positive breast cancer. Semin Oncol. 2020 Oct;47(5):259-269. doi: 10.1053/j.seminoncol.2020.07.008. Epub 2020 Aug 18.
PubMed 32896428Zhao W, Bian L, Wang T, Zhang S, Li J, Xu F, Jiang Z. Effectiveness of second-line anti-HER2 treatment in HER2-positive metastatic breast cancer patients previously treated with trastuzumab: A real-world study. Chin J Cancer Res. 2020 Jun;32(3):361-369. doi: 10.21147/j.issn.1000-9604.2020.03.07.
PubMed 32694900Kelly P, Ma Z, Baidas S, Moroose R, Shah N, Dagan R, Mamounas E, Rineer J. Patterns of Progression in Metastatic Estrogen Receptor Positive Breast Cancer: An Argument for Local Therapy. Int J Breast Cancer. 2017;2017:1367159. doi: 10.1155/2017/1367159. Epub 2017 Sep 25.
PubMed 29147583Weickhardt AJ, Scheier B, Burke JM, Gan G, Lu X, Bunn PA Jr, Aisner DL, Gaspar LE, Kavanagh BD, Doebele RC, Camidge DR. Local ablative therapy of oligoprogressive disease prolongs disease control by tyrosine kinase inhibitors in oncogene-addicted non-small-cell lung cancer. J Thorac Oncol. 2012 Dec;7(12):1807-1814. doi: 10.1097/JTO.0b013e3182745948.
PubMed 23154552
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STereotactic Body Radiotherapy (SBRT) After oligoprogRession Metastatic Breast Cancer (STAR-B)
- ClinicalTrials.gov ID
- NCT06489821
- Acronym / sponsor ID
- STAR-B / STAR-B
- Conditions
- Metastatic Breast Cancer, Oligoprogression
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Juravinski Cancer CenterUniversity, hospital or other
- Collaborators
- Juravinski Cancer Centre Foundation
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- 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.
Recent advances in systemic therapy have facilitated improved progression-free survival (PFS) and treatment tolerability in metastatic breast cancer patients (MBC). Oligoprogression (OP) refers to progression limited to five or fewer sites in otherwise controlled systemic disease on a drug therapy. Stereotactic body radiotherapy (SBRT) has the potential to locally ablate resistant OP lesions that develop on a systemic treatment, and may consequently delay the need for change in drug therapy, delay time to chemotherapy and prolong PFS. This is a phase II trial of SBRT plus continuation of current systemic therapy line for OP MBC patients, to determine rate of delay of change in systemic therapy of at six months. PFS, time to chemotherapy and quality of life will also be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapy | Experimental | Radiation: Stereotactic body radiotherapySBRT in 5 or 2 (or 4) fractions for body and spine respectively over 2 weeks, while continuing first line systemic therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of progressive metastatic breast cancer on first line systemic therapy, including either hormone receptor positive, Her-2 negative (HR+/Her2-) on endocrine therapy + CDK4/6 inhibitor or Her-2 positive (hormone receptor positive or negative /Her2+) on Her2-targeted therapy regimens.
- Progressive disease limited to "oligoprogression", defined as progression of 5 or fewer extra-cranial lesions with otherwise controlled systemic disease on current line of systemic therapy.
- Patients must have previously controlled disease for at least six months on current systemic therapy
- Deemed a candidate for stereotactic body radiotherapy (SBRT) to all OP lesions
Key exclusion criteria (10 listed)
- Requires change in systemic therapy line at the time of OP as determined by medical oncologist;
- Progression on 2nd line or subsequent lines of therapy
- Lacks CT or bone scan Imaging within previous 45 days;
- Progression in >3 sites in the liver or lung;
- Hormone positive disease on endocrine therapy only at time of enrollment;
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 |
|---|---|---|
| Stereotactic body radiotherapyStereotactic body radiotherapy in 5 fractions (body) or 2 or 4 fractions (spine) plus continuation of first line systemic therapy | Radiation | Stereotactic body radiotherapy (SBRT) plus continuation of first line systemic therapy |
Primary outcome
Percentage of patients with change in systemic therapy
Time frame: Six months
Change in systemic therapy will occur with progression with the following criteria: 1. Progression not amenable to further SBRT, including multifocal (>3) sites; 2. Progression in lesion not amenable to further SBRT; 3. Rapid progression such that treating medical oncologist believes change in therapy is warranted; 4. Progression in location including, including visceral metastasis, such that treating medical oncologist believes change in therapy is warranted
5 secondary outcomes
Progression-free survival
Time frame: 3, 6, 12, 18, and 24 months
Local progression
Time frame: 3, 6, 12, 18, and 24 months
Time to chemotherapy
Time frame: 3, 6, 12, 18, and 24 months
Overall Survival
Time frame: 3, 6, 12, 18, and 24 months
CTCAE Toxicity
Time frame: 3, 6, 12, 18, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Background: PubMed 25524798Finn RS, Crown JP, Lang I, Boer K, Bondarenko IM, Kulyk SO, Ettl J, Patel R, Pinter T, Schmidt M, Shparyk Y, Thummala AR, Voytko NL, Fowst C, Huang X, Kim ST, Randolph S, Slamon DJ. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Oncol. 2015 Jan;16(1):25-35. doi: 10.1016/S1470-2045(14)71159-3. Epub 2014 Dec 16.
- Background: PubMed 27959613Finn RS, Martin M, Rugo HS, Jones S, Im SA, Gelmon K, Harbeck N, Lipatov ON, Walshe JM, Moulder S, Gauthier E, Lu DR, Randolph S, Dieras V, Slamon DJ. Palbociclib and Letrozole in Advanced Breast Cancer. N Engl J Med. 2016 Nov 17;375(20):1925-1936. doi: 10.1056/NEJMoa1607303.
- Background: PubMed 26947331Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol. 2016 Apr;17(4):425-439. doi: 10.1016/S1470-2045(15)00613-0. Epub 2016 Mar 3.
- Background: PubMed 27717303Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Blackwell KL, Andre F, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Petrakova K, Hart LL, Villanueva C, Chan A, Jakobsen E, Nusch A, Burdaeva O, Grischke EM, Alba E, Wist E, Marschner N, Favret AM, Yardley D, Bachelot T, Tseng LM, Blau S, Xuan F, Souami F, Miller M, Germa C, Hirawat S, O'Shaughnessy J. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016 Nov 3;375(18):1738-1748. doi: 10.1056/NEJMoa1609709. Epub 2016 Oct 7.
- Background: PubMed 29718092Hortobagyi GN, Stemmer SM, Burris HA, Yap YS, Sonke GS, Paluch-Shimon S, Campone M, Petrakova K, Blackwell KL, Winer EP, Janni W, Verma S, Conte P, Arteaga CL, Cameron DA, Mondal S, Su F, Miller M, Elmeliegy M, Germa C, O'Shaughnessy J. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann Oncol. 2018 Jul 1;29(7):1541-1547. doi: 10.1093/annonc/mdy155.
- Background: PubMed 32171426Swain SM, Miles D, Kim SB, Im YH, Im SA, Semiglazov V, Ciruelos E, Schneeweiss A, Loi S, Monturus E, Clark E, Knott A, Restuccia E, Benyunes MC, Cortes J; CLEOPATRA study group. Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study. Lancet Oncol. 2020 Apr;21(4):519-530. doi: 10.1016/S1470-2045(19)30863-0. Epub 2020 Mar 12.
- Background: PubMed 31091374Andre F, Ciruelos E, Rubovszky G, Campone M, Loibl S, Rugo HS, Iwata H, Conte P, Mayer IA, Kaufman B, Yamashita T, Lu YS, Inoue K, Takahashi M, Papai Z, Longin AS, Mills D, Wilke C, Hirawat S, Juric D; SOLAR-1 Study Group. Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2019 May 16;380(20):1929-1940. doi: 10.1056/NEJMoa1813904.
- Background: PubMed 20855825Di Leo A, Jerusalem G, Petruzelka L, Torres R, Bondarenko IN, Khasanov R, Verhoeven D, Pedrini JL, Smirnova I, Lichinitser MR, Pendergrass K, Garnett S, Lindemann JP, Sapunar F, Martin M. Results of the CONFIRM phase III trial comparing fulvestrant 250 mg with fulvestrant 500 mg in postmenopausal women with estrogen receptor-positive advanced breast cancer. J Clin Oncol. 2010 Oct 20;28(30):4594-600. doi: 10.1200/JCO.2010.28.8415. Epub 2010 Sep 20.
- Background: PubMed 29223745Di Leo A, Johnston S, Lee KS, Ciruelos E, Lonning PE, Janni W, O'Regan R, Mouret-Reynier MA, Kalev D, Egle D, Csoszi T, Bordonaro R, Decker T, Tjan-Heijnen VCG, Blau S, Schirone A, Weber D, El-Hashimy M, Dharan B, Sellami D, Bachelot T. Buparlisib plus fulvestrant in postmenopausal women with hormone-receptor-positive, HER2-negative, advanced breast cancer progressing on or after mTOR inhibition (BELLE-3): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):87-100. doi: 10.1016/S1470-2045(17)30688-5. Epub 2017 Dec 7.
- Background: PubMed 30136059Sammons S, Kornblum NS, Blackwell KL. Fulvestrant-Based Combination Therapy for Second-Line Treatment of Hormone Receptor-Positive Advanced Breast Cancer. Target Oncol. 2019 Feb;14(1):1-12. doi: 10.1007/s11523-018-0587-9.
- Background: PubMed 31825569Murthy RK, Loi S, Okines A, Paplomata E, Hamilton E, Hurvitz SA, Lin NU, Borges V, Abramson V, Anders C, Bedard PL, Oliveira M, Jakobsen E, Bachelot T, Shachar SS, Muller V, Braga S, Duhoux FP, Greil R, Cameron D, Carey LA, Curigliano G, Gelmon K, Hortobagyi G, Krop I, Loibl S, Pegram M, Slamon D, Palanca-Wessels MC, Walker L, Feng W, Winer EP. Tucatinib, Trastuzumab, and Capecitabine for HER2-Positive Metastatic Breast Cancer. N Engl J Med. 2020 Feb 13;382(7):597-609. doi: 10.1056/NEJMoa1914609. Epub 2019 Dec 11.
- Background: PubMed 32896428Bredin P, Walshe JM, Denduluri N. Systemic therapy for metastatic HER2-positive breast cancer. Semin Oncol. 2020 Oct;47(5):259-269. doi: 10.1053/j.seminoncol.2020.07.008. Epub 2020 Aug 18.
- Individual participant dataSharing planned: No
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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.
Kyle McGowan contact
Kyle McGowan study director
Juravinski CC
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic body radiotherapy in people with Metastatic Breast Cancer and Oligoprogression, run by Juravinski Cancer Center.
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 4 inclusion and 10 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: opening soon, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elysia K Donovan, MD MSc FRCPC DABR (905 387 9495 ext. 63123, donovane@hhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients with change in systemic therapy (time frame: Six months). 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 NCT06489821, which also lists 29 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 8 Jul 2024.