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Low-dose Tamoxifen For Stage 1 Breast Cancer

Who Should Use Tamoxifen

Low-dose tamoxifen as effective as higher doses for breast cancer patients

Tamoxifen can help women and men with hormone receptor-positive breast cancer. The drug can lower the risk of breast cancer in:

  • Women who are high-risk of breast cancer due to a family history of disease or mutated breast cancer genes.
  • Women and men who have already been diagnosed with breast cancer to prevent recurrence of cancer, including:
  • Development of breast cancer in the opposite, untreated breast.
  • American Cancer Society. Breast Cancer Hormone Receptor Status. Accessed 11/18/2021.
  • American Cancer Society. Hormone Therapy for Breast Cancer. Accessed 11/18/2021.
  • American Cancer Society. Tamoxifen and Raloxifene for Lowering Breast Cancer Risk. Accessed 11/18/2021.
  • BreastCancer.org. Low-Dose Tamoxifen May Be an Option to Reduce Risk of Recurrence, Invasive Disease After Non-Invasive Breast Cancer. Accessed 11/18/2021.
  • BreastCancer.org. Tamoxifen . Accessed 11/18/2021.
  • National Breast Cancer Foundation. Hormone Therapy. Accessed 11/18/2021.
  • National Cancer Institute. Hormonal Therapy. Accessed 11/18/2021.
  • Susan G. Komen. Side Effects of Tamoxifen. Accessed 11/18/2021.
  • Susan G. Komen. Tamoxifen. Accessed 11/18/2021.
  • Susan G. Komen. Tamoxifen and Raloxifene to Reduce Breast Cancer Risk. Accessed 11/18/2021.
  • Susan G. Komen. Tumor Characteristics: Hormone Receptor Status. Accessed 11/18/2021.

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Systemic Treatments For Stage 1 Breast Cancer

Systemic treatments, often termed add-on or adjuvant treatments, treat breast cancer throughout your body and not just at the site of the tumor.

These treatments help destroy cancer cells that have spread beyond your breast but are still too small to be spotted. They include the therapies outlined below.

Chemotherapy

Doctors may recommend chemotherapy, also called chemo, after surgery to help destroy any undetected cancer cells. Chemotherapy may also lower your risk of the cancer coming back at a later stage.

Chemotherapy may be recommended for a smaller tumor if:

  • Any cancer cells were found in the lymph nodes.
  • You score high on a gene test such as Oncotype DX, which shows whether chemotherapy could help treat your breast cancer and if its likely to come back after surgery.
  • The cancer cells are progesterone receptor- and estrogen receptor-negative.
  • The breast cancer cells are positive for human epidermal growth factor receptor 2 various therapies can target these receptors.

Hormone therapy

Hormone therapy can be used to help slow down the growth of cancer cells in people with estrogen receptor-positive or progesterone receptor-positive cancer cells. Hormone therapy works by blocking hormone receptors on the cancer cells or by lowering the amount of estrogen produced in your body.

Its important to ask your doctor about the potential side effects of hormone therapy before you begin this treatment, so can you know what to expect.

Targeted therapy

Local Percutaneous Administration Of Drugs To The Breast: Setting The Stage For Topical Tamoxifen For Breast Cancer Prevention

Experience with topical drugs

Transdermal delivery has long been recognized as an effective alternative to conventional systemic therapy, including oral administration. When delivered transdermally, a drug is characterized by distinct pharmacokinetics, with longer retention in the local tissue. However, due to the effectiveness of the barrier function of the stratum corneum, only a relatively small number of lipophilic drugs with low molecular weights have been successfully formulated for these purposes. Among the drugs delivered successfully by the percutaneous route, the reproductive hormones, including HRT and contraceptive patches, are in standard clinical use. Progesterone was the first hormone tested for local treatment in benign breast diseases . Topical daily application of progesterone, 50 mg in hydroalcoholic gel for 3 months, was efficacious in treating benign breast diseases . This benefit resulted from local antiestrogenic activity of progesterone in the breast .

Preclinical studies have been comparing 4-OHT with endoxifen, which is expected to have a stronger antiestrogenic effect . However, the permeation of endoxifen into human skin was not as efficient as that of 4-OHT in a vehicle of 60% ethanol-phosphate buffer. The addition of 1% oleic acid greatly improved permeation of endoxifen over a 24-hour period .

Proof-of-principle studies paving the way for topical tamoxifen

Phase II-B study of 4-OHT gel in women with DIN

Read Also: Do Phytoestrogens Cause Breast Cancer

Breast Cancer Support And Resources

If youve received a diagnosis of breast cancer, you may be feeling fearful and anxious. But you are not alone. You may want to consider reaching out to a breast cancer support group or online community for help, advice, and resources.

Many other people are dealing with exactly the same questions and concerns that you are. And many people have also survived breast cancer and can provide invaluable advice and support.

You may want to:

  • Join an online community to connect with other people affected by breast cancer. The Healthline Breast Cancer app may be a good place to find emotional support and connect with others who are on the same journey as you.

Local Treatment: Surgery And Radiation

About the Oncoytpe DX Breast Recurrence Score®

If you receive a diagnosis of stage 1 breast cancer, your doctor may recommend local treatments such as surgery and radiation therapy to treat your breast cancer at the site.

Both lumpectomy and mastectomy are options for stage 1 breast cancer. Your doctor will help determine what is right for you based on the tumor size, grade, and level of spread.

  • Lumpectomy. Also known as breast-conserving surgery, a lumpectomy is the least invasive surgery for breast cancer. With this procedure, a surgeon will remove the tumor and some surrounding tissue, but will leave as much of your breast as possible so that it looks a lot like the original breast.
  • Mastectomy. A mastectomy involves the removal of the entire breast. There are different types of mastectomies. Some types of mastectomies involve the removal of the lymph nodes. Other types can preserve the breast skin or the nipple and areola, especially with early stage breast cancer.

Doctors typically recommend radiation therapy after a lumpectomy for stage 1 breast cancer treatment. Radiation therapy helps destroy any cancer cells that may have been left behind after the surgery. This helps lower the chance of the breast cancer coming back.

Radiation is less often needed after a mastectomy with stage 1 breast cancer.

Beyond local treatments, your doctor might recommend systemic treatments for stage 1 breast cancer.

Also Check: Treatment For Breast Cancer Stage 1

Receptor Status Of Breast Cancer Cells

Breast cancer cells are tested to determine whether they have any of the following receptors:

  • Estrogen receptors: estrogen receptor-positive or estrogen receptor-negative status
  • Progesterone receptors: progesterone receptor-positive or progesterone receptor-negative status
  • HER2 : human epidermal growth factor receptor 2-positive or human epidermal growth factor receptor 2-negative status

The type of treatment thats recommended for stage 1 breast cancer will depend on a variety of factors, such as:

Clinical Trials Of Low Dose Tamoxifen In Combination With Other Agents

Tamoxifen and fenretinide

The hypothesis that tamoxifen and fenretinide offer a potentially beneficial combination derived from animal studies showing a synergistic effect of the two agents on the inhibition of mammary carcinogenesis . A phase III clinical trial showed that the potential preventive efficacy of fenretinide was evident only in premenopausal women . Based on these findings, a randomized double-blind 2 × 2 factorial design trial was implemented . A total of 235 premenopausal women diagnosed with pT1mic/pT1a breast cancer or intraepithelial neoplasia, or 5-year Gail risk 1.3% were randomly allocated to tamoxifen 5 mg/day, fenretinide 200 mg/day, their combination, or placebo. During the 2-year intervention, tamoxifen significantly lowered IGFI and mammographic density by 12% and 20%, respectively, fenretinide lowered them by 4% and 10% , and their combination did so by 20% and 22%, with no evidence for a synergistic interaction. The combination of low-dose tamoxifen plus fenretinide did not reduce breast neoplastic events compared to placebo, whereas both single agents, particularly fenretinide, showed numerical reduction of breast neoplasms .

Tamoxifen and aromatase inhibitors

Tamoxifen and hormone replacement therapy

Low-dose tamoxifen and intraepithelial neoplasia

Ongoing trials of low-dose tamoxifen

Read Also: How Often Does Breast Cancer Spread To Brain

Could Tamoxifen Dose Be Slasheddown To 25 Mg

Roxanne Nelson, RN, BSN

Tamoxifen has long been used in breast cancer, both in the adjuvant and preventive setting, but uptake and adherence are notoriously low, mainly because of adverse events.

Using a much lower dose to reduce the incidence of side effects would be a “way forward,” reasoned Swedish researchers. They report that a substantially lower dose of tamoxifen may be as effective as the standard dose , but reduced by half the incidence of severe vasomotor symptoms, including hot flashes, cold sweats, and night sweats.

The research was March 18 in the Journal of Clinical Oncology.

The study involved 1439 women who were participating in the Swedish mammography screening program and tested tamoxifen at various doses.

“We performed a dose determination study that we hope will initiate follow-up studies that in turn will influence both adjuvant treatment and prevention of breast cancer,” said lead author Per Hall, MD, PhD, head of the Department of Medical Epidemiology and Biostatistics at Karolinska Institutet in Stockholm, Sweden.

The study measured the effects of the different doses on mammographic breast density.

Hall emphasized that breast density was used as a proxy for therapy response. “We do not know how that translates to actual clinical effect,” he told Medscape Medical News. “This is step one.”

Taking A Lower Dose Of Tamoxifen

Low-dose tamoxifen halved recurrence of breast intraepithelial neoplasia

Given the risk of endometrial cancer from tamoxifen, which apparently increases with dosage, length of use, and the age of the patient, is anyone taking a lower dose in order to extend adherence and soften side effects?

I did find an article about endometrial hyperplasia, and even polyps, but I didnt find any studies that found an increase in endometrial carcinoma. All are a problem but if you have a link to any information. I would love to read it.Pubchem lists two dosages, 10 mg, and 20 mg. As to which you would typically be prescribed, I have no idea, but at least there are choices.That being said if you are troubled by the possibility of endometrial changes or have you discussed this with your doctor? Maybe considering a different drug?

Hi Vivi, I noticed that you wished to post a URL to a resource with your post. You will be able to add URLs to your posts in a few days. There is a brief period where new members can’t post links. We do this to deter spammers and keep the community safe. Clearly the link you wanted to post is not spam. Please allow me to post it for you.

Tamoxifen and Uterine Cancer

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What Is Hormone Receptor

Breast cancer tumors that are hormone receptor-positive need the hormones estrogen or progesterone to grow. Approximately 75% of breast cancers are hormone-positive in post-menopausal patients. Your healthcare provider will perform a biopsy and laboratory testing to determine the cancer type and most effective treatment.

How Breast Cancer Cells Are Graded

  • G1. Cells are well differentiated this is considered low grade.
  • G2. Cells are moderately differentiated this is considered intermediate grade.
  • G3. Cells are poorly differentiated this is considered high grade.

Your healthcare team will also test the cancer cells for receptors that are located on the outside of the cells. Knowing which receptors are present can help determine what type of treatment is likely to be more effective.

Read Also: Genes Associated With Breast Cancer

Axillary Radiotherapy And Lymph Node Surgery Produce Similar Outcomes

Early-stage breast cancer patients may be safe in choosing either radiation of the axillary lymph nodes or surgery to remove the nodes when cancer is detected in a sentinel lymph node , said the authors of a study presented December 6 at the annual meeting of the San Antonio Breast Cancer Symposium.

Typically, women with early-stage breast cancer have sentinel lymph nodes removed during the time of surgery to look for signs that cancer has spread beyond the breast. When cancer is detected, these patients usually undergo removal of the axillary lymph nodes, too. But this surgery can cause side effects, including swelling and difficulty moving the arm. The new trial, called AMAROS, was a phase 3 study to test whether radiotherapy of the axillary lymph nodes could be as beneficial as surgery to remove the axillary lymph nodes but with fewer side effects.

The study involved 1,425 patients who were randomly assigned to radiation or surgery and then were followed for 10 years. The findings showed radiation therapy is linked to significantly less lymphedema compared with surgery. Overall survival in the two groups was 81.4 percent and 84.6 percent, respectively.

“The appearance of lymphedema in the radiation therapy group was half that of patients who had surgery, and this maintains over the years, says Mila Donker, MD, PhD, a radiation oncologist at the Netherlands Cancer Institute in Amsterdam and the lead author of the study.

Whole Breast Radiation Has Slightly Better Outcomes Than Accelerated Partial Breast Radiation But Some Women May Still Opt For The Latter

About the Oncoytpe DX Breast Recurrence Score®

Early-stage breast cancer patients who undergo lumpectomy may undergo a protocol to irradiate the entire breast, which typically includes a treatment time of three to six weeks, or an accelerated, partial-breast radiation protocol that can be completed in five to eight days.

A study presented December 6 at the San Antonio Breast Cancer Symposium, designed to look at whether an accelerated course of partial-breast radiation therapy is comparable to radiation of the whole breast, showed the outcomes are close but that whole-breast radiation produced slightly better outcomes in breast cancer recurrence and 10-year survival rates.

The difference in the percentage of patients who survived 10 years without a relapse was statistically significant: 91.9 percent for patients treated with partial-breast irradiation and 93.4 percent for patients treated with whole-breast irradiation. The authors said that because partial-breast irradiation is less burdensome, women may still choose that option.

The American Society for Radiation Oncology provides guidelines on which patients are appropriate candidates for partial-breast irradiation. Individual patient circumstances play a role in the decision-making, such as when women are unable to commit to six weeks of radiation therapy.

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Women Appear To Prevent Recurrence In Early Stage Cancers With 5 Mg Dosing

SAN ANTONIO A low-dose treatment of tamoxifen 5 mg daily rather than the conventional 20 mg daily appears to offer women protection against recurrence of early stage breast cancer and also reduces adverse events that often accompany tamoxifen cancer prevention therapy, researchers reported here.

After a median follow-up of 5.1 years, women diagnosed with breast intraepithelial neoplasia who took 5 mg of tamoxifen for 3 years had 14 breast cancer events compared with 28 events among women in the study who were assigned to placebo , reported Andrea De Censi, MD, director of the medical oncology unit at the National Hospital E.O. Ospedali Galliera S.C. Oncologia Medica in Genoa, Italy.

“Our phase III TAM-01 study shows that a lower dose of tamoxifen 5 mg per day given for 3 years decreases by 52% the risk of a recurrence in women with breast intraepithelial neoplasia that is, ductal carcinoma in situ , lobular carcinoma in situ, and atypical ductal hyperplasia,” De Censi told MedPage Today at the annual San Antonio Breast Cancer Symposium.

The researchers also reported that tamoxifen appeared to be protective systemically. There were 12 breast cancer events in the contralateral breast among the placebo patients compared with three in the patients taking low-dose tamoxifen .

The results of the study are generalizable, he said, and should be “applicable in clinical practice from tomorrow.”

Disclosures

Effect Modifiers Of Low

Corresponding Author:

Note: Supplementary data for this article are available at Clinical Cancer Research Online .

Trial registration: EudraCT Number: 2007-007740-10 ClinicalTrials.gov Identifier: NCT01357772. Registered 17 May 2011 – Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT01357772.

Prior presentation: Presented orally at the 2019 ASCO annual meeting, Chicago, June 3, 2019.

Corresponding Author:

Clin Cancer Res 2021 27:357683

Clin Cancer Res

  • Accepted Manuscript February 19 2021
  • Andrea DeCensi, Matteo Puntoni, Harriet Johansson, Aliana Guerrieri-Gonzaga, Silvia Caviglia, Franca Avino, Laura Cortesi, Antonio Ponti, Maria Grazia Pacquola, Fabio Falcini, Marcella Gulisano, Maria Digennaro, Anna Cariello, Katia Cagossi, Graziella Pinotti, Matteo Lazzeroni, Davide Serrano, Irene Maria Briata, Tania Buttiron Webber, Luca Boni, Bernardo Bonanni Effect Modifiers of Low-Dose Tamoxifen in a Randomized Trial in Breast Noninvasive Disease. Clin Cancer Res 1 July 2021 27 : 35763583.

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    Using Circulating Tumor Cell Count Aka Liquid Biopsy To Choose Therapy For Advanced Breast Cancer

    A test called circulating tumor cell count may help patients choose between hormone therapy or chemotherapy to treat estrogen receptorpositive HER2-negative metastatic breast cancer, according to a new study by researchers in France presented December 6 at the San Antonio Breast Cancer Symposium in Texas.

    CTC is considered the strongest predictor of patient prognosis for these patients. The study showed that basing a decision between chemotherapy and hormone therapy using CTC counts did not harm patients and led to greater survival rates in patients who were switched to chemotherapy based on their CTC count.

    Modern prognostic biomarkers, such as the CTC count, may lead to better patient survival, says Francois-Clement Bidard, MD, PhD, a professor of medical oncology at Institut Curie in Saint Cloud, France, and the University of Versailles.

    In another study on circulating tumor cell technology presented December 6 in San Antonio, researchers found that a liquid biopsy assessment of the PIK3CA gene mutation was a better indicator of patient outcomes than an assessment using a tissue biopsy.

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