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Breast Cancer FemalePhase 2LALEASTNCT03917082

Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer

A Phase 2 study testing Tamoxifen Citrate in people with Breast Cancer Female and Hormone Receptor Positive Tumor, run by British Columbia Cancer Agency at 1 site in Canada.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis. Read more about this study

Who is it for?
Ages 51 years and older, women only
What is being tested?
Tamoxifen Citrate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
1 siteCanada
Study dates
23 Sep 2019to 1 May 2029
Phase
Phase 2
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 51 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of invasive breast cancer which is:
  • Unifocal or multifocal (not multicentric)
  • Unilateral
  • Moderate or strongly hormone receptor positive
  • HER2 negative
  • Ductal grade 1 or 2, or lobular any grade, or pure tubular (any grade) or pure papillary (any grade). If mixed lobular-ductal histology, the ductal component must be grade 1 or 2.
Show all 22Show fewer
  • Stage pT1N0 (tumor </= 20mm, negative node) or pT2N0 (tumor 21-50mm, node negative) or pT1N0i+ (tumor </=20mm and isolated tumor cells in node[s]) or pT2N0i+ (tumor 21-50mm and isolated tumor cells in node[s]) (see Appendix 2). Tumor size must be sufficient for Prosigna® testing. pNX (nodal status unknown) stage is not eligible.
  • Subject must be female
  • Subject must be age > 50 years at breast cancer diagnosis
  • Subject may be pre, peri, or postmenopausal.
  • Subject must have a > 5-year life expectancy based on physician judgement of subject's co-morbid illnesses and age
  • Subject must undergo standard of care loco-regional management (sentinel node biopsy and/or axillary dissection; breast conserving surgery or mastectomy; radiation to breast following breast conserving surgery, with radiotherapy details per local institution practice). Surgery will have been no more than 24 weeks prior to endocrine therapy start. Subjects having repeat surgeries after radiation, regardless of indication, should count the date of last surgery that preceded radiation. Subjects may undergo Prosigna® screening prior to completion of radiation.
  • The breast surgery will have achieved negative surgical margins. Tumours with positive margins that are not re-resectable are eligible if followed by radiation with a boost (partial mastectomy) or chest wall radiation (mastectomy)
  • No (neoadjuvant or adjuvant) chemotherapy given or planned for this breast cancer
  • No other non-breast cancer within the last 5 years, except non-melanoma skin cancer, melanoma in situ, cervix carcinoma in situ, and anal carcinoma in situ
  • No prior hormone receptor positive invasive breast cancer. Prior contralateral DCIS treated with standard of care local therapy, and prior lobular carcinoma in situ (LCIS) are allowed, provided no endocrine therapy with any of tamoxifen, ovarian suppression, raloxifene, or aromatase inhibitor was given
  • Subject will have not have started endocrine therapy prior to enrollment
  • Subject has signed a screening informed consent form
  • Subject has intent to be adherent to endocrine therapy for two years in the absence of serious toxicity
  • Prosigna® score in the low risk range, defined as an ROR of 40 or lower
  • Subject has not yet initiated endocrine therapy
  • Subject has signed study informed consent form

Who cannot join

  • Does not meet every inclusion criteria listed above

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • BC Cancer

    Vancouver, British Columbia, V5Z4E6

Other trials in Canada

About this study

Official title: LA LEAST- Luminal A, Limited Endocrine Adjuvant Systemic Therapy. A Trial of Abbreviated Hormone Therapy for Low Risk Hormone Receptor Positive, HER2 Negative Early Breast Cancer

Phase II trial of 2 years of standard adjuvant endocrine therapy after low risk hormone receptor positive, HER2 negative, node negative breast cancer in women older than 50 at diagnosis.

The study hypothesis is that reducing adjuvant endocrine therapy from 5 to 2 years in a population with low risk of breast cancer; as determined by histopathologic criteria and confirmed by low risk genomic analysis using Prosigna®; will be safe and acceptable to this population, and will not compromise the expected excellent breast cancer specific outcomes for this population.

Read the detailed description

Women older than 50 at diagnosis of an invasive breast cancer which is all of: node negative/N0i+; T1 or T2; low or intermediate grade; with strong or intermediate expression of hormone receptors (ER and PR); and HER2 negative, and who have had adequate local therapy for their tumor, are invited to participate in Prosigna® screening. A sample of their excised tumor is sent for Prosigna® testing. This is a validated and widely approved genomic test to assess recurrence risk in hormone receptor positive/HER2 negative, node negative breast tumors. Tumors with a low risk result, defined as Risk of Recurrence (ROR) less than or equal to 40, are then eligible for enrollment on the LA LEAST study of 2 years of endocrine therapy (tamoxifen for pre/perimenopausal women and aromatase inhibitor for postmenopausal women). To mimic real life, there is flexibility to switch to an alternate standard of care endocrine therapy during the two years if intolerable side effects develop. During the two years of therapy, participants are seen every six months and complete periodic quality of life (QOL) questionnaires designed to measure quality of life, mood, side effects, and anxiety/fear of recurrence. Following two years of therapy, participants have annual study visits until year 10, with similar questionnaires at some but not all time points, and assessment of study endpoints. Primary endpoint is the 5 year distant relapse free interval (DRFI), defined as freedom from distant recurrence or breast cancer death at five years. Secondary endpoints include longitudinal QOL comparisons, 10 year breast cancer free interval and 10 year contralateral breast cancer rate. It is anticipated that about 400 individuals will need to be screened to enroll 290 participants with requisite low score. The sample size is based on an expected 5 year DRFI of 96.8%, one sided alpha of 0.05 and a rejection of the alternate hypothesis if the lower boundary of the one sided confidence interval yields an observed DRFI below 95%.

Being tested
Tamoxifen Citrate
Keywords
endocrine therapy

What participants receive

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

  • Tamoxifen CitrateDrug

    Also called aromatase inhibitor

    current standard of care is 5 years endocrine therapy after early breast cancer. Intervention will test if 2 years is adequate for population with low recurrence risk based on genomic tissue based test

Study groups in NCT03917082
Study groupRoleWhat they receive
standard of care endocrine therapy for two yearsExperimentalStandard of care adjuvant endocrine therapy for two years. for postmenopausal women, initial therapy will be aromatase inhibitor unless contraindicated, in which case tamoxifen may be used. For premenopausal and perimenopausal women, initial therapy will be tamoxifen unless contraindicated, in which case an lutenizing hormone releasing hormone (LHRH) agonist with / without aromatase inhibitor may be used.
Receives: Drug: Tamoxifen Citrate

What is being measured

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

  1. Distant Relapse Free Interval at five years

    freedom from distant recurrence or breast cancer death at 5 years

    Measured: 5 years after the last patient is enrolled

Secondary outcomes (2)

  1. Ten year breast cancer free interval

    freedom from local, regional, distant breast cancer recurrence or death from breast cancer or ipsilateral or contralateral ductal carcinoma in situ or contralateral invasive breast cancer at ten years

    Measured: ten years after the last patient is enrolled

  2. Ten year contralateral breast cancer incidence

    breast cancer occurring in the contralateral breast, including ductal carcinoma in situ (DCIS) and invasive breast cancer, within ten years of enrollment.

    Measured: ten years after the last patient is enrolled

Timeline

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

  1. First posted16 Apr 2019
  2. Study start23 Sep 2019
  3. Primary completion1 May 2026 (estimated)
  4. Study completion1 May 2029 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm phase II study exploring reducing the duration of endocrine therapy from five to two years in low risk population with early breast cancer
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03917082
Sponsor's protocol ID
LA LEAST
Acronym
LALEAST
Status last verified
Jun 2023
First submitted
18 Mar 2019
Last updated
15 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: summary results for participants will be shared in peer review meetings and publications

Publications

  • Burstein HJ, Temin S, Anderson H, Buchholz TA, Davidson NE, Gelmon KE, Giordano SH, Hudis CA, Rowden D, Solky AJ, Stearns V, Winer EP, Griggs JJ. Adjuvant endocrine therapy for women with hormone receptor-positive breast cancer: american society of clinical oncology clinical practice guideline focused update. J Clin Oncol. 2014 Jul 20;32(21):2255-69. doi: 10.1200/JCO.2013.54.2258. Epub 2014 May 27.

    PubMed 24868023

  • Gnant M, Thomssen C, Harbeck N. St. Gallen/Vienna 2015: A Brief Summary of the Consensus Discussion. Breast Care (Basel). 2015 Apr;10(2):124-30. doi: 10.1159/000430488.

    PubMed 26195941

  • Tamoxifen for early breast cancer: an overview of the randomised trials. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1998 May 16;351(9114):1451-67.

    PubMed 9605801

  • 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

  • Ekholm M, Bendahl PO, Ferno M, Nordenskjold B, Stal O, Ryden L. Two Years of Adjuvant Tamoxifen Provides a Survival Benefit Compared With No Systemic Treatment in Premenopausal Patients With Primary Breast Cancer: Long-Term Follow-Up (> 25 years) of the Phase III SBII:2pre Trial. J Clin Oncol. 2016 Jul 1;34(19):2232-8. doi: 10.1200/JCO.2015.65.6272. Epub 2016 May 9.

    PubMed 27161974

  • Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.

    PubMed 14551341

  • Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Cameron DA, Palmer MJ, Pater JL. Randomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17. J Natl Cancer Inst. 2005 Sep 7;97(17):1262-71. doi: 10.1093/jnci/dji250.

    PubMed 16145047

  • Davies C, Pan H, Godwin J, Gray R, Arriagada R, Raina V, Abraham M, Medeiros Alencar VH, Badran A, Bonfill X, Bradbury J, Clarke M, Collins R, Davis SR, Delmestri A, Forbes JF, Haddad P, Hou MF, Inbar M, Khaled H, Kielanowska J, Kwan WH, Mathew BS, Mittra I, Muller B, Nicolucci A, Peralta O, Pernas F, Petruzelka L, Pienkowski T, Radhika R, Rajan B, Rubach MT, Tort S, Urrutia G, Valentini M, Wang Y, Peto R; Adjuvant Tamoxifen: Longer Against Shorter (ATLAS) Collaborative Group. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet. 2013 Mar 9;381(9869):805-16. doi: 10.1016/S0140-6736(12)61963-1.

    PubMed 23219286

  • Goss PE, Ingle JN, Pritchard KI, Robert NJ, Muss H, Gralow J, Gelmon K, Whelan T, Strasser-Weippl K, Rubin S, Sturtz K, Wolff AC, Winer E, Hudis C, Stopeck A, Beck JT, Kaur JS, Whelan K, Tu D, Parulekar WR. Extending Aromatase-Inhibitor Adjuvant Therapy to 10 Years. N Engl J Med. 2016 Jul 21;375(3):209-19. doi: 10.1056/NEJMoa1604700. Epub 2016 Jun 5.

    PubMed 27264120

  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23.

    PubMed 26211827

  • Tjan-Heijnen VCG, van Hellemond IEG, Peer PGM, Swinkels ACP, Smorenburg CH, van der Sangen MJC, Kroep JR, De Graaf H, Honkoop AH, Erdkamp FLG, van den Berkmortel FWPJ, de Boer M, de Roos WK, Linn SC, Imholz ALT, Seynaeve CM; Dutch Breast Cancer Research Group (BOOG) for the DATA Investigators. Extended adjuvant aromatase inhibition after sequential endocrine therapy (DATA): a randomised, phase 3 trial. Lancet Oncol. 2017 Nov;18(11):1502-1511. doi: 10.1016/S1470-2045(17)30600-9. Epub 2017 Oct 12.

    PubMed 29031778

  • Love RR, Van Dinh N, Quy TT, Linh ND, Tung ND, Shen TZ, Hade EM, Young GS, Jarjoura D. Survival after adjuvant oophorectomy and tamoxifen in operable breast cancer in premenopausal women. J Clin Oncol. 2008 Jan 10;26(2):253-7. doi: 10.1200/JCO.2007.11.6061. Epub 2007 Dec 17.

    PubMed 18086800

  • Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. 133 randomised trials involving 31,000 recurrences and 24,000 deaths among 75,000 women. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1992 Jan 11;339(8785):71-85. No abstract available.

    PubMed 1345869

  • Systemic treatment of early breast cancer by hormonal, cytotoxic, or immune therapy. 133 randomised trials involving 31,000 recurrences and 24,000 deaths among 75,000 women. Early Breast Cancer Trialists' Collaborative Group. Lancet. 1992 Jan 4;339(8784):1-15.

    PubMed 1345950

  • Pagani O, Regan MM, Walley BA, Fleming GF, Colleoni M, Lang I, Gomez HL, Tondini C, Burstein HJ, Perez EA, Ciruelos E, Stearns V, Bonnefoi HR, Martino S, Geyer CE Jr, Pinotti G, Puglisi F, Crivellari D, Ruhstaller T, Winer EP, Rabaglio-Poretti M, Maibach R, Ruepp B, Giobbie-Hurder A, Price KN, Bernhard J, Luo W, Ribi K, Viale G, Coates AS, Gelber RD, Goldhirsch A, Francis PA; TEXT and SOFT Investigators; International Breast Cancer Study Group. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10;371(2):107-18. doi: 10.1056/NEJMoa1404037. Epub 2014 Jun 1.

    PubMed 24881463

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tamoxifen Citrate in people with Breast Cancer Female and Hormone Receptor Positive Tumor, run by British Columbia Cancer Agency at 1 site in Canada.

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 22 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2023. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

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?

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?

Distant Relapse Free Interval at five years (time frame: 5 years after the last patient is enrolled). 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 NCT03917082, which also lists 55 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 15 Jun 2023.

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