Trial reportJournal of the National Cancer Institute2019
Adjuvant Anti-HER2 Therapy, Treatment-Related Amenorrhea, and Survival in Premenopausal HER2-Positive Early Breast Cancer Patients.
Trial report in Journal of the National Cancer Institute, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 49 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
49 citing papers in PubMed, 1 synthesis or guideline pooled it, 101 citations in OpenAlex.
- Multidisciplinary consensus on the criteria for fertility preservation in cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2022Guideline
- Impact of Age on Clinical Outcomes and Efficacy of Adjuvant Dual Anti-HER2 Targeted Therapy.Journal of the National Cancer Institute · 2022Trial
- Long-Term Outcomes With Pharmacological Ovarian Suppression During Chemotherapy in Premenopausal Early Breast Cancer Patients.Journal of the National Cancer Institute · 2022Trial
- Fertility in breast cancer survivorship: a scoping review.Journal of cancer survivorship : research and practice · 2026Review
- De-escalated chemotherapy and endocrine therapy outcomes in young women with stage I HR+/HER2+ breast cancer: An international real-world study.Breast (Edinburgh, Scotland) · 2026Observational
- The role of patient age in fertility preservation among women with breast cancer: biological mechanisms and clinical implications.Journal of assisted reproduction and genetics · 2026Review
- Oncofertility in the Age of HER2 Blockade, Immunotherapy, PARP inhibitors, CDK4/6 inhibitors and Endocrine Treatment: Unanswered Questions in Breast Cancer.Current treatment options in oncology · 2026Review
- The Impact of Conventional Chemotherapy Regimens and Targeted Drugs on Ovarian Function in Breast Cancer Patients.Reproductive sciences (Thousand Oaks, Calif.) · 2026Review
- Adjuvant ovarian function suppression and aromatase inhibitors in premenopausal patients with hormone receptor and HER2 positive breast cancer, by timing of chemotherapy and trastuzumab and response to neoadjuvant therapy.Breast (Edinburgh, Scotland) · 2026Article
- Optimizing adjuvant endocrine therapy in premenopausal patients with HER2-positive, hormone receptor-positive breast cancer.Breast (Edinburgh, Scotland) · 2026Article
- Impact of immunotherapy and small molecule cancer therapy on fertility: a narrative review of current evidence, mechanisms and future directions.BMJ oncology · 2026Review
- [Fertility management in breast cancer patients: current strategies and research advances].Zhejiang da xue xue bao. Yi xue ban = Journal of Zhejiang University. Medical sciences · 2025Review
- Gonadotoxicity of immunotherapy and targeted agents in patients with cancer and impact on subsequent pregnancies.Human reproduction (Oxford, England) · 2025Review
- Patterns, Predictors, and Prognostic Implication of Treatment-Related Amenorrhea in Patients With Breast Cancer.World journal of oncology · 2025Article
- Fertility in early breast cancer patients: integrating reproductive planning into oncology care.Frontiers in endocrinology · 2025Review
- Pregnancy after breast cancer: latest evidence and practical considerations.Therapeutic advances in medical oncology · 2025Review
- Balancing Fertility Preservation and Treatment Efficacy in (Neo)adjuvant Therapy for Adolescent and Young Adult Breast Cancer Patients: a Narrative Review.Current oncology reports · 2024Review
- Breast cancer Treatment and Fertility Preservation: A Narrative Review of Impacts, Strategies and Ethical Considerations.Current oncology reports · 2024Review
- Menstrual Blood Stem Cells-Derived Exosomes as Promising Therapeutic Tools in Premature Ovarian Insufficiency Induced by Gonadotoxic Systemic Anticancer Treatment.International journal of molecular sciences · 2024Review
- Impact of Systemic Therapy on Fertility in Women with Early-Stage Breast Cancer.Current breast cancer reports · 2024Article
Corrections and comments
- Commented on by
- Erratum issuedCorrigendum.2019
Authors and funding
22 authors at 19 institutions in 11 countries.
Funding
Abstract
Background: In premenopausal patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer, the gonadotoxicity of trastuzumab and lapatinib remains largely uncertain, and the prognostic effect of treatment-related amenorrhea (TRA) is unknown. Methods: In the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (BIG 2-06) phase III trial, HER2-positive early breast cancer patients were randomized (1:1:1:1) to receive one year of trastuzumab, lapatinib, their sequence, or their combination. As per study protocol, menopausal status was collected in all patients at random assignment and at week 37 visit. We investigated TRA rates and whether TRA in patients with hormone receptor-positive and -negative tumors would impact disease-free survival (DFS) and overall survival (OS). Landmark and time-dependent modeling were used to account for guarantee-time bias. All statistical tests were two-sided. Results: A total of 2862 premenopausal women were included, of whom 1679 (58.7%) had hormone receptor-positive disease. Median age was 43 (interquartile range = 38-47) years. Similar TRA rates were observed in the trastuzumab (72.6%), lapatinib (74.0%), trastuzumab→lapatinib (72.1%), and trastuzumab+lapatinib (74.8%) arms (P = .64). The association between TRA and survival outcomes differed according to hormone-receptor status (Pinteraction for DFS = .007; Pinteraction for OS = .003). For hormone receptor-positive patients, the TRA cohort had statistically significantly better DFS (adjusted hazard ratio [aHR] = 0.58, 95% confidence interval [CI] = 0.45 to 0.76) and OS (aHR = 0.63, 95% CI = 0.40 to 0.99) than the no TRA cohort. No difference was observed in hormone receptor-negative patients. Conclusions: In this unplanned analysis, no association between TRA rate and type of anti-HER2 treatment was observed. TRA was associated with statistically significant survival benefits in premenopausal hormone receptor-positive/HER2-positive early breast cancer patients.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.