Breast Cancer—Local/Regional/Adjuvant

Oncoletter provides you with quotes from the abstract's conclusions. To see more, go the ASCO Meeting Library while clicking on the link of the study-titles (to see videos and slides needs a payable registration)

William J. Gradishar: ASCO 2020 Report — Breast Cancer  Highlights of the latest treatments

500 Primary analysis of KAITLIN: A phase III study of trastuzumab emtansine (T-DM1) + pertuzumab versus trastuzumab + pertuzumab + taxane, after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer (EBC).

Nadia Harbeck, Seock-Ah Im, Carlos H. Barrios, et al. (Interview mit Nadia Harbeck HIER)

The abstract concludes: Replacing adjuvant taxane and trastuzumab with T-DM1 did not result in significantly improved efficacy or overall safety. Nonetheless, in this high-risk population, a favorable IDFS outcome was achieved in both study arms. HP + chemotherapy remains the standard of care for patients with high-risk HER2-positive EBC. Clinical trial information: NCT01966471.

See the report in the ASCO DAILY NEWS: 

T-DM1 Does Not Improve Safety or Efficacy in HER2-Positive Early Breast Cancer; Favorable iDFS Reported

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501 Three-year follow-up of neoadjuvant chemotherapy with or without anthracyclines in the presence of dual HER2-blockade for HER2-positive breast cancer (TRAIN-2): A randomized phase III trial.

Anna van der Voort, Mette S. van Ramshorst, Erik D. van Werkhoven, et al

The abstract concludes: The 3-year follow-up of the TRAIN-2 study confirms the results of the primary outcome that anthracylines do not improve efficacy and are associated with clinically relevant toxicity. A neoadjuvant carboplatin-taxane based regimen with dual HER2-blockade can be considered in all stage II-III breast cancer patients, regardless of hormone receptor and nodal status. Clinical trial information: NCT01996267.

See the report about Abstract 501 & 503 in the ASCO DAILY NEWS:

Strategies Emerge for Chemotherapy De-escalation in HER2-Positive Breast Cancer

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502 Biomarker data from KATHERINE: A phase III study of adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab (H) in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer.

Carsten Denkert, Chiara Lambertini, Peter A. Fasching, et al.

The abstract concludes: These exploratory analyses provide the first data on the relationship between biomarker expression in residual disease after HER2-targeted therapy and outcomes. PIK3CA mut status did not influence outcomes with H or T-DM1. T-DM1 benefit appeared to be independent of all biomarkers assessed. Clinical trial information: NCT01772472.

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503 Chemotherapy (CT) de-escalation using an FDG-PET/CT (F-PET) and pathological response-adapted strategy in HER2[+] early breast cancer (EBC): PHERGain Trial.

Javier Cortes, Geraldine Gebhart, Manuel Ruiz Borrego, et al.

The abstract concludes: F-PET identify pts with HER2[+] EBC who are more likely to benefit from CT-free dual HER2-blockade with HP. Follow-up is ongoing for iDFS endpoint. Depending on the results of this second co-primary endpoint, this strategy could select a group of HER2[+] EBC pts who would not need CT. Clinical trial information: NCT03161353.

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504 ALTERNATE:  Neoadjuvant endocrine treatment (NET) approaches for clinical stage II or III estrogen receptor-positive HER2-negative breast cancer (ER+ HER2- BC) in postmenopausal (PM) women: Alliance A011106.

Cynthia X. Ma, Vera J. Suman, A. Marilyn Leitch, et al. (Interview zum Thema mit Christian Jackisch, Offenbach)

The abstract concludes: Neither F nor F+A significantly improved ESDR compared to A alone in PM pts with locally advanced ER+ HER2- BC. RFS data are awaited. Support: U10CA180821, U10CA180882, U24CA196171, https://acknowledgments.alliancefound.org; NCI BIQSFP, BCRF, Genentech, AstraZeneca. Clinical trial information: NCT01953588.

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505 Letrozole + ribociclib versus letrozole + placebo as neoadjuvant therapy for ER+ breast cancer (FELINE trial).

Qamar J. Khan, Anne O'Dea, Aditya Bardia, et al. (Interview zum Thema mit Christian Jackisch, Offenbach)

The abstract concludes: Addition of R to L as NET did not result in more women with a PEPI score of 0. At D14C1 twice as many women on L+R had CCCA compared to L+P (92% vs 52%). However, significantly more women on L+R had increased proliferation between D14C1 and surgery, resulting in similar CCCA at surgery. Correlative studies are being performed to determine mechanisms of on-therapy acquired resistance to ribociclib. Continuous and intermittent doses of R have similar efficacy, toxicity. Clinical trial information: NCT02712723.

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506 MINDACT: Long-term results of the large prospective trial testing the 70-gene signature MammaPrint as guidance for adjuvant chemotherapy in breast cancer patients.

Fatima Cardoso, Laura van 't Veer, Coralie Poncet, et al. (Interview zum Thema mit Christian Jackisch, Offenbach)

The abstract concludes: The primary DMFS endpoint at 5 years continues to be met in CT untreated C-High / G-Low risk women, confirming MINDACT as a positive de-escalation study. With longer follow-up and in line with the natural history of luminal breast cancer, more distant relapses do occur but the estimated gain of 2.6% for CT administration in C-High / G-Low patients remains small in light of CT harmful effects. The level IA evidence for the clinical utility of the 70-gene signature for adjuvant CT decision making is maintained. Clinical trial information: NCT00433589.

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507 Phase III trial of metronomic capecitabine maintenance after standard treatment in operable triple-negative breast cancer (SYSUCC-001).

XI Wang, Shu-Sen Wang, Heng Huang, et al. (Interview zur Studie mit Michael Untch, Berlin-Buch)

The abstract concludes: Maintenance therapy with metronomic capecitabine for one year following standard treatment significantly improved DFS in operable TNBC, which was safe and well tolerated. (SYSUCC-001, Clinical trial information: NCT01112826.

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508 Primary results of NRG Oncology / NSABP B-43: Phase III trial comparing concurrent trastuzumab (T) and radiation therapy (RT) with RT alone for women with HER2-positive ductal carcinoma in situ (DCIS) after lumpectomy.

Melody A. Cobleigh, Stewart J. Anderson, Kalliopi P. Siziopikou, et al.

The abstract concludes: The addition of T to RT did not achieve the protocol objective of 36% reduction in the IBTR rate but did achieve a modest, statistically non-significant reduction of 19%. Support: U10-180868, -180822, UG1-189867; Genentech. The authors thank Elaina Harper and Marlon Jones for data management. Clinical trial information: NCT00769379.

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Highlighted abstract from the poster session:

Poster Session

584 Inhibiting fatty acid synthase in operable triple negative breast cancer.

Sagar D. Sardesai, Alexandra Thomas, Christopher Gallagher, et al. 

The abstract concludes: 

Consistent with previous studies, FASN is frequently expressed in early stage TNBC. OMP can be safely administered in doses that inhibit FASN. The addition of high dose OMP to neoadjuvant AC-T yields a promising pCR rate without adding toxicity. Funded by the Breast Cancer Research Foundation. Clinical trial information: NCT02595372.